Systems and methods for guiding injections

ABSTRACT

Systems and methods are described herein for guided injection, which include: one or more controllable light-emitting elements configured to emit non-destructive light and a computing device operably connected to the one or more controllable light-emitting elements configured to emit non-destructive light, the computing device including a processor operable to receive at least one digital representation of a body region of an individual, the body region of the individual including one or more physical registration landmarks, the at least one digital representation including one or more digitally registered injection sites and one or more digital registration landmarks corresponding to the one or more physical registration landmarks on the body region; and control the one or more controllable light-emitting elements to illuminate a location of a surface of the body region of the individual corresponding in location to at least one of the one or more digitally registered injection sites.

CROSS-REFERENCE TO RELATED APPLICATIONS

If an Application Data Sheet (ADS) has been filed on the filing date ofthis application, it is incorporated by reference herein. Anyapplications claimed on the ADS for priority under 35 U.S.C. §§119, 120,121, or 365(c), and any and all parent, grandparent, great-grandparent,etc. applications of such applications, are also incorporated byreference, including any priority claims made in those applications andany material incorporated by reference, to the extent such subjectmatter is not inconsistent herewith.

The present application is related to and/or claims the benefit of theearliest available effective filing date(s) from the following listedapplication(s) (the “Priority Applications”), if any, listed below(e.g., claims earliest available priority dates for other thanprovisional patent applications or claims benefits under 35 USC §119(e)for provisional patent applications, for any and all parent,grandparent, great-grandparent, etc. applications of the PriorityApplication(s)). In addition, the present application is related to the“Related Applications,” if any, listed below.

Priority Applications:

None.

Related Applications:

-   -   U.S. patent application Ser. No. 13/664,273, entitled SYSTEMS        AND METHODS FOR GENERATING AN INJECTION GUIDE, naming Edward S.        Boyden, Gregory J. Della Rocca, Daniel Hawkins, Roderick A.        Hyde, Robert Langer, Eric C. Leuthardt, Terence Myckatyn, Parag        Jitendra Parikh, Dennis J. Rivet, Joshua S. Shimony, Michael A.        Smith, and Clarence T. Tegreene as inventors, filed 30 Oct. 2012        is related to the present application.    -   U.S. patent application Ser. No. 13/567,921, entitled DEVICES        AND METHODS FOR WEARABLE INJECTION GUIDES, naming Mahalaxmi Gita        Bangera, Edward S. Boyden, Hon Wah Chin, Gregory J. Della Rocca,        Daniel Hawkins, Roderick A. Hyde, Muriel Y. Ishikawa, Jordin T.        Kare, Robert Langer, Eric C. Leuthardt, Stephen L. Malaska,        Terence Myckatyn, Parag Jitendra Parikh, Dennis J. Rivet,        Joshua S. Shimony, Michael A. Smith, Elizabeth A. Sweeney,        Clarence T. Tegreene, Sharon L. Wolda, and Lowell L. Wood, Jr.        as inventors, filed 6 Aug. 2012 is related to the present        application.    -   U.S. patent application Ser. No. 13/567,995, entitled DEVICES        AND METHODS FOR WEARABLE INJECTION GUIDES, naming Mahalaxmi Gita        Bangera, Edward S. Boyden, Hon Wah Chin, Gregory J. Della Rocca,        Daniel Hawkins, Roderick A. Hyde, Muriel Y. Ishikawa, Jordin T.        Kare, Robert Langer, Eric C. Leuthardt, Stephen L. Malaska,        Terence Myckatyn, Parag Jitendra Parikh, Dennis J. Rivet,        Joshua S. Shimony, Michael A. Smith, Elizabeth A. Sweeney,        Clarence T. Tegreene, Sharon L. Wolda, and Lowell L. Wood, Jr.        as inventors, filed 6 Aug. 2012 is related to the present        application.    -   U.S. patent application Ser. No. 13/568,033, entitled SYSTEMS        AND METHODS FOR WEARABLE INJECTION GUIDES, naming Mahalaxmi Gita        Bangera, Edward S. Boyden, Hon Wah Chin, Gregory J. Della Rocca,        Daniel Hawkins, Roderick A. Hyde, Muriel Y. Ishikawa, Jordin T.        Kare, Robert Langer, Eric C. Leuthardt, Stephen L. Malaska,        Terence Myckatyn, Parag Jitendra Parikh, Dennis J. Rivet,        Joshua S. Shimony, Michael A. Smith, Elizabeth A. Sweeney,        Clarence T. Tegreene, Sharon L. Wolda, and Lowell L. Wood, Jr.        as inventors, filed 6 Aug. 2012 is related to the present        application.

The United States Patent Office (USPTO) has published a notice to theeffect that the USPTO's computer programs require that patent applicantsreference both a serial number and indicate whether an application is acontinuation, continuation-in-part, or divisional of a parentapplication. Stephen G. Kunin, Benefit of Prior-Filed Application, USPTOOfficial Gazette Mar. 18, 2003. The USPTO further has provided forms forthe Application Data Sheet which allow automatic loading ofbibliographic data but which require identification of each applicationas a continuation, continuation-in-part, or divisional of a parentapplication. The present Applicant Entity (hereinafter “Applicant”) hasprovided above a specific reference to the application(s) from whichpriority is being claimed as recited by statute. Applicant understandsthat the statute is unambiguous in its specific reference language anddoes not require either a serial number or any characterization, such as“continuation” or “continuation-in-part,” for claiming priority to U.S.patent applications. Notwithstanding the foregoing, Applicantunderstands that the USPTO's computer programs have certain data entryrequirements, and hence Applicant has provided designation(s) of arelationship between the present application and its parentapplication(s) as set forth above and in any ADS filed in thisapplication, but expressly points out that such designation(s) are notto be construed in any way as any type of commentary and/or admission asto whether or not the present application contains any new matter inaddition to the matter of its parent application(s).

To the extent that the listings of applications provided above may beinconsistent with the listings provided via an ADS, it is the intent ofthe application to claim priority to all applications listed in thePriority Applications section of either document.

All subject matter of the Priority Applications and the RelatedApplications and of any and all parent, grandparent, great-grandparent,etc. applications of the Priority Applications and the RelatedApplications, including any priority claims, is incorporated herein byreference to the extent such subject matter is not inconsistentherewith.

SUMMARY

In an aspect, a system for guiding injection in an individual includes,but is not limited to: one or more controllable light-emitting elementsconfigured to emit non-destructive light; and a computing deviceoperably connected to the one or more controllable light-emittingelements configured to emit non-destructive light, the computing deviceincluding a processor operable to receive at least one digitalrepresentation of a body region of the individual, the body region ofthe individual including one or more physical registration landmarks,the at least one digital representation including one or more digitallyregistered injection sites and one or more digital registrationlandmarks corresponding to the one or more physical registrationlandmarks on the body region; and control the one or more controllablelight-emitting elements to illuminate a location on a surface of thebody region of the individual corresponding in location to at least oneof the one or more digitally registered injection sites. In addition tothe foregoing, other system aspects are described in the claims,drawings, and text forming a part of the present disclosure.

In an aspect, a method for guiding injection in an individual includes,but is not limited to: illuminating one or more injection sites in aninjection-treatment pattern on a surface of a body region of theindividual in accordance with an injection-treatment plan; and injectingat least one injectable agent into an underlying tissue of the bodyregion at or near at least one of the one or more illuminated injectionsites. In addition to the foregoing, other method aspects are describedin the claims, drawings, and text forming a part of the presentdisclosure.

In an aspect, a method for guiding injection in an individual includes,but is not limited to: projecting an injection-treatment pattern on asurface of a body region of the individual, the injection-treatmentpattern part of a digitally-rendered injection-treatment plan andincluding one or more illuminated injection sites; placing one or moremarks on the surface of the body region of the individual, the one ormore mark substantially corresponding in location to the one or moreilluminated injection sites; and injecting at least one injectable agentinto an underlying tissue of the body region of the individual at ornear at least one of the one or more marks. In addition to theforegoing, other method aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In an aspect, a system includes, but is not limited to: a computerprocessor; and non-transitory signal-bearing medium bearing one or moreinstruction for registering illuminated injection sites, thenon-transitory signal-bearing medium including one or more instructionsfor acquiring a real-time image of a body region of an individual; oneor more instructions for locating one or more physical registrationlandmarks on the real-time image of the body region of the individual;one or more instructions for matching the one or more physicalregistration landmarks with one or more digital registration landmarksin an injection-treatment plan, the injection treatment plan includingone or more digital injection sites; one or more instructions formapping the one or more digital injection sites to one or more physicalinjection sites; and one or more instructions for controllingillumination of the one or more physical injection sites. In addition tothe foregoing, other system aspects are described in the claims,drawings, and text forming a part of the present disclosure.

In an aspect, an article of manufacture includes, but is not limited to:non-transitory signal-bearing medium bearing one or more instructionsfor guiding injection in an individual, the non-transitorysignal-bearing medium including one or more instructions including oneor more instructions for referencing one or more digitally registeredsites on a three-dimensional model of a body region of the individualwith one or more digital injection sites; and one or more instructionsfor controlling illumination of injection information for each digitalinjection site onto a surface of the body region of the individual. Inaddition to the foregoing, other article of manufacture aspects aredescribed in the claims, drawings, and text forming a part of thepresent disclosure.

In an aspect, a method implemented on a computing device for generatingan injection guide includes, but is not limited to: receiving one ormore digital images of a body region of an individual, the body regionincluding one or more physical registration landmarks; generating atleast one digital representation of the body region using the one ormore digital images, the at least one digital representation includingone or more digital registration landmarks corresponding to the one ormore physical registration landmarks on the body region; adding one ormore digitally registered injection sites to the at least one digitalrepresentation of the body region in an injection-treatment pattern, theone or more digitally registered injection sites registered relative tothe one or more digital registration landmarks; and generating one ormore output signals having information for controlling one or morecontrollable light-emitting elements to illuminate a location on asurface of the body region of the individual corresponding in locationto at least one of the one or more digitally registered injection sites.In addition to the foregoing, other method aspects are described in theclaims, drawings, and text forming a part of the present disclosure.

In an aspect, a system includes, but is not limited to: a computerprocessor; and non-transitory signal-bearing medium bearing one or moreinstructions for generating an injection guide, the non-transitorysignal-bearing medium including one or more instructions for receivingone or more digital images of a body region of an individual includingone or more physical registration landmarks; one or more instructionsfor generating at least on digital representation of the body regionusing the one or more digital images, the at least one digitalrepresentation including one or more digital registration landmarkscorresponding to the one or more physical registration landmarks on thebody region; one or more instructions for adding one or more digitallyregistered injection sites to the at least one digital representation ofthe body region, the one or more digitally registered injection sitesregistered relative to the one or more digital registration landmarks;and one or more instructions for generating one or more output signalshaving information for controlling one or more controllablelight-emitting elements to illuminate a location on a surface of thebody region of the individual corresponding in location to at least oneof the one or more digitally registered injection sites. In addition tothe foregoing, other system aspects are described in the claims,drawings, and text forming a part of the present disclosure.

In an aspect, an article of manufacture includes, but is not limited to:non-transitory signal-bearing medium bearing one or more instructionsfor generating an injection guide, the non-transitory signal-bearingmedium including one or more instructions for receiving one or moredigital images of a body region of an individual including one or morephysical registration landmarks; one or more instructions for generatingat least one digital representation of the body region using the one ormore digital images, the at least one digital representation includingone or more digital registration landmarks corresponding to the one ormore physical registration landmarks on the body region; one or moreinstructions for adding one or more digitally registered injection sitesto the at least one digital representation of the body region, the oneor more digitally registered injection sites registered relative to theone or more digital registration landmarks; and one or more instructionsfor generating one or more output signals having information forcontrolling one or more controllable light-emitting elements toilluminate a location on a surface of the body region of the individualcorresponding in location to at least one of the one or more digitallyregistered injection sites. In addition to the foregoing, other articleof manufacture aspects are described in the claims, drawings, and textforming a part of the present disclosure.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic of an embodiment of a system for guiding injectionin an individual.

FIG. 2 is a schematic of an embodiment of a computing device.

FIG. 3 is a schematic of an embodiment of a system for guiding injectionin an individual.

FIG. 4 is a flow-diagram of an embodiment of a method for guidinginjection in an individual.

FIG. 5 is a schematic of an embodiment of a system for guiding injectionin an individual.

FIGS. 6A-6C are schematics of an embodiment of a system for guidinginjection in an individual mounted on a head region of a user.

FIGS. 7A-7C are schematics of an embodiment of a system for guidinginjection in an individual at first, second, and third illuminatedinjection sites.

FIG. 8 is a schematic of an embodiment of a system for guiding injectionin an individual.

FIGS. 9A & 9B are schematics of an embodiment of a system for guidinginjection in an individual with an injector-tracking device.

FIGS. 10A & 10B are schematics of an embodiment of an injector-trackingdevice.

FIGS. 11A & 11B are schematics of an embodiment of an injector-trackingdevice.

FIG. 12 is a flowchart of a method of guiding injection in anindividual.

FIG. 13 is a flowchart illustrating aspects of a method such as shown inFIG. 12.

FIG. 14 is a flowchart showing aspects of a method such as depicted inFIG. 12.

FIG. 15 is a flowchart depicting aspects of a method such as illustratedin FIG. 12.

FIG. 16 is a flowchart illustrating aspects of a method such as shown inFIG. 12.

FIG. 17 is a flowchart showing aspects of a method such as depicted inFIG. 12.

FIG. 18 is a flowchart depicting aspects of a method such as illustratedin FIG. 12.

FIG. 19 is a flowchart illustrating aspects of a method such as shown inFIG. 12.

FIG. 20 is a flowchart showing aspects of a method such as depicted inFIG. 12.

FIG. 21 is a flowchart of a method for generating an injection guide.

FIG. 22 is a flowchart illustrating aspects of a method such as shown inFIG. 21.

FIG. 23 is a flowchart showing aspects of a method such as depicted inFIG. 21.

FIG. 24 is a flowchart depicting aspects of a method such as illustratedin FIG. 21.

FIG. 25 is a flowchart illustrating aspects of a method such as shown inFIG. 21.

FIG. 26 is a flowchart showing aspects of a method such as depicted inFIG. 21.

FIG. 27 is a flowchart depicting aspects of a method such as illustratedin FIG. 21.

FIG. 28 is a flowchart illustrating aspects of a method such as shown inFIG. 21.

FIG. 29 is a schematic of an embodiment of a system for generating aninjection guide.

FIG. 30 is a schematic of an embodiment of a system such as shown inFIG. 29.

FIG. 31 is a schematic of an embodiment of a system such as shown inFIG. 29.

FIG. 32 is a schematic of an embodiment of a system for generating aninjection guide.

FIG. 33 is a schematic of an embodiment of a system such as shown inFIG. 29.

FIG. 34 is a schematic of an embodiment of a system such as shown inFIG. 29.

FIG. 35 is a schematic of an embodiment of a system for generating aninjection guide.

FIG. 36 is a schematic of an article of manufacture.

FIG. 37 is a schematic of a system for guiding injection in anindividual.

FIG. 38 is a schematic of a method for guiding injection in anindividual.

FIGS. 39A & 39B are schematics of an embodiment of a system for guidinginjection in an individual for fertility treatment.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description and drawings are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presented here.

Systems and methods are described for generating and using illuminatedinjections guides on a surface of a body region of an individual. Theinjection guides can be used to guide injection of at least oneinjectable agent into a body region of an individual for treatment ofone or more conditions. The systems and methods for generating and usingthe injection guides can be configured for use on any of a number ofbody regions of an individual including but not limited to the face,torso, abdomen, head, neck, upper extremity, lower, extremity, buttocks,or any other body region assessable for needle injection. The systemsand methods for generating and using the injection guides can be usedfor guiding injection of injectable agents used to treat any of a numberof conditions including but not limited to a cosmetic condition (e.g.,wrinkles, sagging skin), pain (e.g., migraine), neurological disorder(e.g., idiopathic neuropathy), neuromuscular disorder (e.g., cervicaldystonia, blepharospasm), inflammation (e.g., arthritis, psoriasis),vascular disorder (e.g., varicose veins, rosacea, Reynaud's Syndrome),cancer, infection (e.g., bacterial or viral infection), endocrinecondition, metabolic condition (e.g., diabetes), infertility (e.g.,ovulatory stimulation for in vitro fertilization), or vitamin deficiency(e.g., vitamin B deficiency). The at least one injectable agent caninclude any of a number of injectable agents including but not limitedto neurotoxins, subcutaneous volume enhancers, dermal fillers, insulin,antibiotics, hormones, anti-inflammatory agents, chemotherapeuticagents, or biological agents.

In an embodiment, a system for guiding injection in an individualincludes one or more controllable light-emitting elements configured toemit non-destructive light; and a computing device operably connected tothe one or more controllable light-emitting elements configured to emitnon-destructive light, the computing device including a processoroperable to receive at least one digital representation of a body regionof an individual, the body region of the individual including one ormore physical registration landmarks, the at least one digitalrepresentation including one or more digitally registered injectionsites and one or more digital registration landmarks corresponding tothe one or more physical registration landmarks on the body region; andcontrol the one or more controllable light-emitting elements toilluminate a location on a surface of the body region of the individualcorresponding in location to at least one of the one or more digitallyregistered injection sites.

With reference to FIG. 1, shown is a schematic view of an embodiment ofa system for guiding injection in an individual. System 100 of FIG. 1includes controllable light-emitting element 110 emitting light 120 ontothe surface of body region 140 of individual 150 to illuminate injectionsite 130. Illuminated injection site 130 on body region 140 ofindividual 150 is a target for injection of an injectable agent withinjector 135. System 100 further includes computing device 160.Computing device 160 is operable to receive one or more digitalrepresentations of body region 140 of an individual 150, including oneor more physical registration landmarks. The one or more digitalrepresentations include one or more digitally registered injectionsites. Computing device 160 is further operable to control controllablelight-emitting element 110 to emit light 120 on the surface of bodyregion 140 of individual 150 corresponding in location to at least oneof the one or more digitally registered injection sites.

System 100 includes one or more controllable light-emitting elementsconfigured to emit non-destructive light, e.g., light of a wavelength,intensity, and/or energy that is non-destructive and/or non-damaging tocells and/or tissue of a body region, including the eyes. In general,light radiation, e.g., laser radiation, is categorized by the UnitedStates Food and Drug Administration (FDA) as follows: class I levels oflaser radiation are considered non-hazardous, although hazard increaseswith optical aids, including magnifiers, binoculars, or telescopes;class IIa levels of laser radiation are considered non-hazardous ifviewed for any period of time less than or equal to 1000 seconds but areconsidered to be a chronic viewing hazard for any period of time greaterthan 1000 seconds; class II levels of laser radiation are considered tobe a chronic viewing hazard; class Ma levels of laser radiation areconsidered to be, depending upon the irradiance, either an acuteintrabeam viewing hazard or chronic viewing hazard, and an acute viewinghazard if viewed directly with optical instruments; class IIIb levels oflaser radiation are considered to be an acute hazard to the skin andeyes from direct radiation; and class IV levels of laser radiation areconsidered to be an acute hazard to the skin and eyes from direct andscattered radiation (see, e.g., 21CFR1040.10, Code of FederalRegulations, Title 21, Volume 8, Chapter 1, Subchapter J, RadiologicalHealth, which is incorporated herein by reference). It is contemplatedthat the controllable light-emitting elements for use with the systemdescribed herein would exclude either class Mb or class IV levels ofradiation unless some type of corrective measures are used to reduce thehazard to either skin or tissue, including the eyes.

In one embodiment, the one or more controllable light-emitting elementsare configured to illuminate a location on a surface of the body regionof the individual corresponding in size and shape to at least one of oneor more digitally registered injection sites included in the at leastone digital representation of the body region. In one embodiment, thesize of the illuminated portion of the body region is highly focused,e.g., not much larger in cross-sectional diameter than thecross-sectional diameter of a needle associated with an injector (e.g.,about 0.2 to 4.5 millimeters). This configuration may be appropriate forinjections that require precise placement of the needle into theunderlying tissue. In one embodiment, the size of the illuminatedportion of the body region is broader, e.g., a patch of light on thesurface of the body region. This configuration may be appropriate forinjections that can accommodate needle placement in a more general orgross area of the underlying tissue, where accurate placement of theneedle is not as important or multiple injections are required in thesame general location.

In one embodiment, the one or more controllable light-emitting elementsconfigured to emit non-destructive light include one or more of acontrollable light-emitting diode, a laser, a laser diode, a collimatedlight source, or a focused light source. In one embodiment, the one ormore controllable light-emitting elements include one or morelight-emitting diodes (LEDs), semiconductor light sources available in avariety of colors and sizes. In one embodiment, the one or morecontrollable light-emitting elements include one or more lasers,non-limiting examples of which include solid-state lasers (e.g.,neodymium-Yag laser), gas lasers (e.g., helium lasers), excimer lasers(e.g., chlorine or fluorine mixed with inert gases), and dye lasers(e.g., rhodamine 6G lasers). In one embodiment, the one or morecontrollable light-emitting elements include one or more laser diodes,semiconductor lasers which may be incorporated into large arrays. In oneembodiment, the one or more controllable light-emitting elements includeone or more collimated light sources. For example, light from a laserdiode or LED may be collimated by passing the light through one or morecollimating lens to achieve a narrower band of emitted light. Forexample, a divergent beam of light emitted from an LED can be collimatedwith one or more lens and/or curved mirrors. In one embodiment, the oneor more controllable light-emitting elements include one or more focusedlight sources, in which light from a source has been focused with one ormore lens to a relatively small point of light.

In one embodiment, the one or more controllable light-emitting elementsinclude one or more controllable projectors. Examples of projectorsinclude but are not limited to movie projectors, video projectors, imageprojectors, slide projectors, and the like. In one embodiment, the oneor more projectors include one or more miniaturized projectors, e.g.,handheld projectors, pocket projectors, mobile projectors, picoprojectors, or mini beamers. The one or more miniaturized projectors caninclude digital light processing, beam-steering, and/or light crystal onsilicon technologies.

In one embodiment, at least one of the one or more controllablelight-emitting elements illuminates a location on the surface of thebody region with at least one of a color or pattern of light indicativeof at least one treatment parameter. In one embodiment, the color oflight emitted by the one or more controllable light-emitting elements isderived from a colored light source, e.g., a light-emitting diode (LED),laser, or laser diode emitting light of a specific wavelength, spectrum,or color. In one embodiment, the color of light emitted by the one ormore controllable light-emitting elements is derived from one or morecolored filters placed so as to modulate the color of light emitted by acontrollable light-emitting element. For example, the color of lightemitted may be controlled by one or more colored filters placed in thepath of white light emitted from one or more light-emitting elements. Inone embodiment, the color of light emitted by the one or morecontrollable light-emitting elements is derived from a projected colorimage that includes projected injection sites of a specific color.

In one embodiment, the pattern of light emitted by the at least one ofthe one or more controllable light-emitting elements comprises a dot orspot, a crosshair, a circle, concentric circles, or crosshairs. In oneembodiment, the pattern of light emitted by the at least one of the oneor more controllable light-emitting elements includes one or more of aletter, number, shape, symbol, or combinations thereof.

The pattern of light emitted from the one or more controllablelight-emitting elements to illuminate a surface of a body region can beformed using any of a number of methods, non-limiting examples of whichinclude beam/splitting, multispot, beam shaping, or TopHat. In oneembodiment, a form of beam shaping is performed to generate a particularpattern of illuminated light from the controllable light-emittingelements. In one embodiment, beam transformers perform a one-to-onemapping of points in an input plane to points in an output plane, anon-limiting example of which is a Gaussian-to-TopHat shaper for asingle-mode laser. In one embodiment, band-limited diffusers,diffractive beamsplitters, and/or beam integrators can be used toperform a many-to-one mapping of points in one plane to multiple pointsin another plane of the beam. The beam is broken up into multiplebeamlets and either overlapped (beam integration) or directed intodifferent directions (diffusers and beam splitters). For example, lightemitted from laser diodes can be shaped into a variety of patterns,e.g., linear, square, rectangle, grid, round, elliptical,circle/concentric circles, crosshair, or scope using beam-shapingoptics, e.g., beam splitters and/or pattern generators, examples ofwhich are commercially available (from, e.g., Frankfurt Laser Company,Freidrichsdorf, Germany). For example, light emitted from LEDs can becollected, collimated and then diffused to shape the beam of light usingLED LightShapters™ and Engineered Diffusers™ (from RPC Photonics, Inc.,Rochester, N.Y.). In one embodiment, the patterns, e.g., circles, dotmatrix, grid, line, square, or crosshair, can be generated using anoptical projection head (from, e.g., Edmund Optics, Inc., Barrington,N.J.) attached to a laser or laser diode. Beam splitters, beam shapers,diffusers, Fourier holograms for generating structured light patternsare also available from HOLOEYE Systems Inc., Carlsbad, Calif.; Holo/OrLtd., Rehovot, Israel; Coherent Inc., Santa Clara, Calif.; and Luminit,LLC, Torrance, Calif.

In one embodiment the pattern of light emitted by the one or morecontrollable light-emitting elements is derived from one or morephysical lighting template, e.g., a gobo, placed in the path of theemitted light (from e.g., InLight Gobos, Dallas Tex.).

In one embodiment, the pattern of light emitted by the one or morecontrollable light-emitting elements to illuminate one or more injectionsites is part of a projected image, the projected image includingprojected injection sites.

In one embodiment, the one or more illuminated injection sites are roundin shape. However, the shape of the one or more illuminated injectionsites is not restricted to being circular in shape and can include, forexample, oval, square, rectangular, trapezoid or triangular shapes.

In one embodiment, the one or more illuminated injection sites arelinear in shape, e.g., a line. In one embodiment, an illuminatedinjection site that is linear in shape may be used for serial needlesticks or linear threading along the path of the linear shape. In oneembodiment, the one or more illuminated injection sites can be one ormore straight lines of illuminated light projected onto the surface ofthe body region. In one embodiment, the one or more illuminatedinjection sites can be one or more curved lines of illuminated lightprojected onto the surface of the body region. The one or more straightlines or curved lines of illuminated light can be continuous ordiscontinuous depending upon the preferred injection-treatment pattern.

In one embodiment, the at least one of a color or pattern of lightemitted by the one or more controllable light-emitting elements isindicative of at least one treatment parameter, the at least onetreatment parameter including, but not limited to an injection site, atype of injectable agent for injection at an injection site, a type ofinjector, a dosage of an injectable agent for injection at an injectionsite, a sequence of injecting an injectable agent at an injection site,a timing of injecting an injectable agent at an injection site, aninjection depth for injection of an injectable agent at an injectionsite, or an injection angle for injection of an injectable agent at aninjection site.

In one embodiment, the at least one treatment parameter is part of aninjection-treatment plan indicated for treatment of a specificcondition. The injection-treatment plan can include one or moreinjectable agents, dosing of the one or more injectable agents, timingof dosing of each of the one or more injectable agents, sequence ofdosing of each of the one or more injectable agents, or placement ofinjection of each of the one or more injectable agents. For example, theinjection-treatment plan may be represented by at least one of a coloror pattern of light emitted by the one or more controllablelight-emitting elements indicating the time intervals at which aspecific injectable agent should be repeatedly injected at the same ordifferent illuminated injection sites over a period of time, e.g., overthe course of a 30 to 60 minute office visit. When two or moreinjectable agents are indicated for use in the condition, theinjection-treatment plan may be represented by at least one of a coloror pattern of light emitted by the one or more controllablelight-emitting elements indicative of the sequence of injection of thetwo or more injectable agents.

In one embodiment, the at least one of a color or pattern of lightemitted by the controllable light-emitting elements is indicative of atype of injectable agent to be injected at a given injection site.Non-limiting examples of injectable agents include neurotoxins,subcutaneous dermal enhancers, insulin, antibiotics, hormones,chemotherapeutic agents, anti-inflammatory agents, or other biologicalagents.

Returning to FIG. 1, system 100 includes computing device 160. Computingdevice 160 is operably connected (e.g., communicatively,electromagnetically, magnetically, ultrasonically, optically,inductively, electrically, or capacitively connected, or the like) toone or more controllable light-emitting elements 110. In one embodiment,computing device 160 is operably connected to one or more controllablelight-emitting elements 110 through one or more wired transmissions,e.g., one or more electrical connections. In one embodiment, computingdevice 160 is operably connected to one or more controllablelight-emitting elements 110 through one or more wireless transmissions,e.g., one or more radio frequency transmissions. Wired transmission canfurther include, but is not limited to, transmission through one or moreof a telephone line, cable line, internet line, fiber optic line,coaxial cable, UPT/STP or any other like wired communication line.Wireless transmission can further include, but is not limited to, one ormore radio transmission, microwave transmission (e.g., wireless LAN,Wi-Fi, wireless PAN, Bluetooth, wireless WAN, 2G/3G, broadband, MAN,WiMAX, radar and satellite communications), or infrared transmission(e.g., point-to-point or broadcast communication).

FIG. 2 illustrates further embodiments of a computing device. Computingdevice 200 includes a processing unit 221, a system memory 222, and asystem bus 223 that couples various system components including thesystem memory 222 to the processing unit 221. Processing unit 221 caninclude a microprocessor, a central processing unit (CPU), a digitalsignal processor (DSP), an application-specific integrated circuit(ASIC), a field programmable gate entry (FPGA), or the like, or anycombinations thereof, and can include discrete digital or analog circuitelements or electronics, or combinations thereof. In one embodiment, thecomputing device includes one or more ASICs having a plurality ofpredefined logic components. In one embodiment, the computing deviceincludes one or more FPGA having a plurality of programmable logiccommands.

The system bus 223 may be any of several types of bus structuresincluding a memory bus or memory controller, a peripheral bus, and alocal bus using any of a variety of bus architectures. By way ofexample, and not limitation, such architectures include IndustryStandard Architecture (ISA) bus, Micro Channel Architecture (MCA) bus,Enhanced ISA (EISA) bus, Video Electronics Standards Association (VESA)local bus, and Peripheral Component Interconnect (PCI) bus, also knownas Mezzanine bus.

The computing device can include one or more computer-readable mediadrives, interface sockets, Universal Serial Bus (USB) ports, memory cardslots, or the like, and one or more input/output components such as, forexample, a graphical user interface, a display, a keyboard, a keypad, atrackball, a joystick, a touch-screen, a mouse, a switch, a dial, or thelike, and any other peripheral device. In one embodiment, one or moreuser input/output components are operably coupled to the computingdevice to control (electrical, electromechanical, software-implemented,firmware-implemented, or other control, or combinations thereof)generation of an injection guide specific to an individual and/or tocontrol illumination from one or more controllable light-emittingelements.

The system memory includes read-only memory (ROM) 224 and random accessmemory (RAM) 225. A basic input/output system (BIOS) 226, containing thebasic routines that help to transfer information between sub-componentswithin computing device 200, such as during start-up, is stored in theROM 224. A number of program modules may be stored in the ROM 224 or RAM225, including an operating system 227, one or more application programs228, other program modules 229 and program data 230.

A user may enter commands and information into the computing device 200through user input devices, such as a number of switches and buttons,illustrated as hardware buttons 244, connected to the system via asuitable non-removable non-volatile memory interface 245. Input devices231 may further include a touch-sensitive display with suitable inputdetection circuitry, illustrated as a display 232 and screen inputdetector 233. The output circuitry of the touch-sensitive display 232 isconnected to the system bus 223 via a video driver 237. Other inputdevices may include a microphone 234 connected through a suitable audiointerface 235, and a physical hardware keyboard 210. Output devices mayinclude at least one display 232, or a projector 236.

In addition to the display 232, the computing device 200 may includeother peripheral output devices, such as at least one speaker 238. Otherexternal input devices 231 or output devices 239, such as a joystick,game pad, satellite dish, scanner or the like, may be connected to theprocessing unit 221 through a USB port 240 and USB port interface 241,to the system bus 223. Alternatively, the other external input devices231 and output devices 239 may be connected by other interfaces, such asa parallel port, game port or other port. The computing device 200 mayfurther include or be capable of connecting to a flash card memory (notshown) through an appropriate connection port (not shown). The computingdevice 200 may further include or be capable of connecting with anetwork through a network port 242 and network interface 243, andthrough wireless port 246 and corresponding wireless interface 247 maybe provided to facilitate communication with other peripheral devices,including light-emitting elements, image capture devices, othercomputers, printers, and so on (not shown). It will be appreciated thatthe various components and connections shown are examples and othercomponents and means of establishing communication links may be used.

A user may enter commands and information into the computing device 200through input device 231 such as a microphone, keyboard, or pointingdevice, commonly referred to as a mouse, trackball, or touch pad. Otherinput devices may include at least one of a touch sensitive display,joystick, game pad, satellite dish, and scanner. These and other inputdevices are often connected to the processing unit through a user inputinterface that is coupled to the system bus, but may be connected byother interface and bus structures, such as a parallel port, game port,or a universal serial bus (USB).

The computing device 200 may be designed to include a user interface.The user interface may include a character, a key-based, or another userdata input including a keyboard or touch sensitive display. The userinterface may include a stylus (not shown). Moreover, the user interfaceis not limited to an actual touch-sensitive panel arranged for directlyreceiving input, but may alternatively or in addition respond to anotherinput device such as the microphone 234. For example, spoken words maybe received at the microphone 234 and recognized.

In certain instances, the computing system typically includes a varietyof computer-readable media products. Computer-readable media may includeany media that can be accessed by the computing device 200 and mayinclude both volatile and nonvolatile media, removable and non-removablemedia. By way of example, and not of limitation, computer-readable mediamay include computer storage media. By way of further example, and notof limitation, computer-readable media may include a communicationmedia. By way of further example, and not of limitation, computerreadable media may include non-transitory signal bearing media.

Communication media may typically embody computer-readable instructions,data structures, program modules, or other data in a modulated datasignal such as a carrier wave or other transport mechanism, and includeany information delivery media. The term “modulated data signal” means asignal that has one or more of its characteristics set or changed insuch a manner as to encode information in the signal. By way of example,and not limitation, communication media may include wired media, such asa wired network and a direct-wired connection, and wireless media suchas acoustic, RF, optical, and infrared media.

The computing device 200 may also include other removable/non-removable,volatile/nonvolatile computer storage media products. For example, suchmedia includes a non-removable non-volatile memory interface (hard diskinterface) 245 reads from and writes for example to non-removable,non-volatile magnetic media, or a removable non-volatile memoryinterface 250 that, for example, is coupled to a magnetic disk drive 251that reads from and writes to a removable, non-volatile magnetic disk252, or is coupled to an optical disk drive 255 that reads from andwrites to a removable, non-volatile optical disk 256, such as a CD ROM.Other removable/nonremovable, volatile/non-volatile computer storagemedia that can be used in the example operating environment include, butare not limited to, magnetic tape cassettes, memory cards, flash memorycards, DVDs, digital video tape, solid state RAM, and solid state ROM.The hard disk drive 257 is typically connected to the system bus 223through a non-removable memory interface, such as the interface 245, andmagnetic disk drive 251 and optical disk drive 255 are typicallyconnected to the system bus 223 by a removable non-volatile memoryinterface, such as interface 250.

The drives and their associated computer storage media discussed aboveprovide storage of computer-readable instructions, data structures,program modules, and other data for the computing device 200.

The computing device may operate in a networked environment usinglogical connections to one or more remote computers, such as a remotecomputer 280. The remote computer 280 may be a personal computer, aserver, a router, a network PC, a peer device, or other common networknode, and typically includes many or all of the elements described aboverelative to the computing device 200. The network logical connectionsinclude a local area network (LAN) and a wide area network (WAN), andmay also include other networks such as a personal area network (PAN)(not shown). Such networking environments are commonplace in offices,enterprise-wide computer networks, intranets, and the Internet.

When used in a networking environment, the computing device is connectedto the network 271 through a network interface, such as the networkinterface 270, the modem 272, or the wireless interface 293. The networkmay include a LAN network environment, or a WAN network environment,such as the Internet. In a networked environment, program modulesdepicted relative to the computing device 200, or portions thereof, maybe stored in a remote memory storage device. By way of example, and notlimitation, remote application programs 285 may reside on computermedium 281. It will be appreciated that the network connections shownare examples and other means of establishing a communication linkbetween the computers may be used.

In certain instances, one or more elements of the computing device 200may be deemed not necessary and omitted. In other instances, one or moreother components may be deemed necessary and added to the computingdevice 200.

In one embodiment, image-based applications such as viewers and/ortoolkits (e.g., Insight Segmentation and Registration Toolkit (ITK)),are incorporated for further intake of information. In one embodiment,CAD implementations or image segmentation may allow processing ofreceived digital images.

In one embodiment, the computing device includes a computer-readablemedia drive or memory slot that is configured to accept non-transitorysignal-bearing medium (e.g., computer-readable memory media,computer-readable recording media, or the like). In one embodiment, aprogram for causing a system to execute any of the disclosed methods canbe stored on, for example, a computer-readable recording medium (CRMM),a non-transitory signal-bearing medium, or the like. Non-limitingexamples of signal-bearing media include a recordable type medium suchas magnetic tape, floppy disk, a hard disk drive, Compact Disc (CD), aDigital Video Disk (DVD), Blu-Ray Disc, digital tape, computer memory,or the like, as well as transmission type medium such as a digitaland/or analog communication medium (e.g., fiber optic cable, waveguide,wired communications link, wireless communication link). Furthernon-limiting examples of signal-bearing media include, but are notlimited to, DVD-ROM, DVD-RAM, DVD+RW, DVD-RW, DVD-R, DVD+R, CD-ROM,Super Audio CD, CD-R, CD+R, CD+RW, CD-RW, Video Compact Discs, SuperVideo Discs, flash memory, magnetic tape, magneto-optic disk, MINIDISC,non-volatile memory card, EEPROM, optical disk, optical storage, RAM,ROM, system memory, web server, cloud, or the like.

In one embodiment, the computing device includes one or more modulesoptionally operable for communication with one or more input/outputcomponents that are configured to relay user output/input. In oneembodiment, a module includes one or more instances of electrical,electromechanical, software-implemented, firmware-implemented, or othercontrol devices. Such devices include one or more instances of memory,computing devices, antennas, power or other supplies, logic modules orother signaling modules, gauges or other such active or passivedetection components, piezoelectric transducers, shape memory elements,micro-electro-mechanical systems (MEMS) elements, or other actuators.

FIG. 3 illustrates further embodiments of a system for guiding injectionin an individual. System 300 of FIG. 3 includes a controllablelight-emitting element 310 emitting light 315 onto the surface of bodyregion 320 of individual 325 to illuminate injection site 330.Illuminated injection site 330 on body region 320 of individual 325 is atarget for injection of an injectable agent with injector 335.

System 300 further includes computing device 340. Block diagram 345illustrates further embodiments of computing device 340. Block 350illustrates that computing device 340 is operable to receive at leastone digital representation of a body region of an individual, the bodyregion of the individual including one or more physical registrationlandmarks, the at least one digital representation including one or moredigitally registered injection sites and one or more digitalregistration landmarks corresponding to the one or more physicalregistration landmarks on the body region. In one embodiment, the atleast one digital representation including one or more digitallyregistered injection sites and one or more digital registrationlandmarks corresponding to the one or more physical registrationlandmarks on the body region are received from another device, e.g.,another computing device, an image capture device, or other devicecapable of storing and transmitting the at least one digitalrepresentation. In one embodiment, the at least one digitalrepresentation may be received from a physician or other practitioner ata location remote from computing device 340. For example, the at leastone digital representation may be captured and annotated with one ormore digitally registered injection sites on a computing device in afirst physician's office and transmitted to a second computing device ina second physician's office, other practitioner's office, or a treatmentroom. In the case of self-injection therapy, the at least one digitalrepresentation including one or more digitally registered injectionsites may be sent to a computing device in a system for guidinginjection at the individual's home, place of work, or other locationwhere the individual engages in self-injection. In one embodiment, theat least one digital representation is received internally from oneportion of a computing device to another portion of the computingdevice, having been generated on said computing device using one or moredigital images of the body region of the individual.

Block 350 includes optional blocks 352 and 354. Block 352 illustratescomputing device 340 optionally operable to receive the at least onedigital representation of the body region of the individual through awired transmission or a wireless transmission. For example, computingdevice 340 can include a transceiver unit capable of receiving awireless transmission including information regarding the at least onedigital representation of the body region. In one embodiment, computingdevice 340 can include a port, e.g., a USB port, for wired transmissionof the one or more digital representations of the body region fromanother device, e.g., a computing device and/or an external imagecapture device.

Block 354 illustrates computing device 340 optionally operable toreceive at least one digital representation of a face, head, neck,torso, abdomen, upper extremity, lower extremity, buttocks, or otherbody region accessible for injection by an injectable agent. The bodyregion can further include one or more physical registration landmarks.The one or more physical registration landmarks can include one or moremarkings placed on the body region of the individual. For example, theone or more physical registration landmarks can include one or moremarkings, e.g., washable inks, adhesive dots or stickers, or othermarking agents, placed on the surface of the skin by a physician orother practitioner. In one embodiment, the one or more physicalregistration landmarks include one or more of a pigmentation, pigmentedarea, skin texture pattern, tattoo, blemish, scar, anatomical feature,or subsurface blood vessel on the body region of the individual. Forexample, the one or more physical registration landmarks can include oneor more pigmented areas such as freckles or moles or one or moreanatomical features such as a nose, lip, cheek, eye, brow, joint, orother anatomical features. An extensive list of landmarks of the facialarea, for example, are described in Buckley et al., Am. J. Psychiatry(2005) 162:606-608, which is incorporated herein by reference.

The at least one digital representation of the body region received bythe computing device includes one or more digital registration landmarkscorresponding to the one or more physical registration landmarks on thebody region. In general, the one or more digital registration landmarkscorresponding to the one or more physical registration landmarks on thebody region may be used to register digitally registered injection sitesrelative to illuminated injection sites to ensure that the light emittedfrom the one or more controllable light-emitting elements illuminatesthe proper locations on the surface of the body region of the individualdespite movement of either the individual or the one or morecontrollable light-emitting elements.

The digital representation of the body region includes one or moredigitally registered injection sites. The one or more digitallyregistered injection sites are digital representations of one or moreinjection sites on the body region of the individual. In one embodiment,the one or more digitally registered injection sites are added to adigital representation of the body region prior to the digitalrepresentation being received by the computing device. For example, theone or more digitally registered injection sites may be added to the atleast one digital representation of the body region by a physician orother practitioner. In one embodiment, the one or more digitallyregistered injection sites are added automatically to the at least onedigital representation of the body region based on a computationalanalysis. The one or more digitally registered injection sites can beregistered relative to one or more of the digital registrationlandmarks, the one or more digital registration landmarks substantiallycorresponding to the one or more physical registration landmarks on thebody region of the individual. For example, a digitally registeredinjection site may be situated at a location represented by XYZcoordinates relative to one or more digital registration landmarks. Theilluminated injection site is similarly situated at the same XYZcoordinates relative to the physical registration landmarks. Methods forregistering points with anatomical image data are provided in Hopenfeldet al., Ann. Biomed. Eng. (2007) 35:1771-1781, which is incorporatedherein by reference.

The one or more digitally registered injection sites correspond inlocation to one or more illuminated injection sites on the body regionof the individual and in one embodiment may be arranged in aninjection-treatment pattern as part of an injection-treatment plan. Theinjection-treatment pattern can include the location of each intendedinjection site as represented by the digitally registered injectionsites. In one embodiment, the injection-treatment pattern can includethe sequence and/or timing of injection at two or more injection sites.The pattern may be specific to the individual or to the condition beingtreated. For example, the injection-treatment pattern may bepredetermined depending upon the type of injectable agent and/or thecondition being treated. For example, cosmetic treatment of a portion ofthe face, e.g., the glabella frown lines, may follow a predeterminedpattern of injection sites. In one embodiment, the predeterminedinjection-treatment pattern is provided by a computing device thatstores injection-treatment patterns specific for a condition, specificfor an injectable agent, and/or specific for an individual.

In one embodiment, the injection-treatment pattern is part of aninjection-treatment plan. In one embodiment, the injection-treatmentplan is specific to the individual. For example, the one or moreilluminated injection sites may be arranged in an injection-treatmentpattern based on the specific needs of the individual for whom theinjection-treatment plan is designed. In this case, the number andplacement of the one or more illuminated injection sites arespecifically prescribed for the individual. In one embodiment, theinjection-treatment plan is specific to a condition in need oftreatment. In one embodiment, the injection-treatment plan is genericfor a given condition. For example, the injection-treatment pattern canbe a series of rows and/or columns of illuminated injection sites, anyone or more of which may be accessed during the course of treatment.

In one embodiment, the one or more injection-treatment plan ispredetermined. For example, the injection-treatment plan may bepredetermined depending upon the type of injectable agent and/or thecondition being treated. For example, cosmetic treatment of a portion ofthe face, e.g., the glabella frown lines, may follow a predeterminedpattern of injection sites. In one embodiment, the predeterminedinjection-treatment plan is provided by a computing device that storesinjection-treatment plans specific for a condition, specific for aninjectable agent, or for a specific individual.

In one embodiment, the injection-treatment plan is anatomical featuredependent. For example, an injection-treatment plan designed for use onthe face of an individual may include a pattern of injections dependentupon a particular anatomical feature of the face, e.g., the eye brow,the glabella, or cheek folds. In one embodiment, the anatomical featurecan include an anatomical feature that might be contraindicated as aninjection site, e.g., an underlying blood vessel, joint, or inside theorbit of the eye, and as such the one or more illuminated injectionsites are located to avoid this anatomical feature. In one embodiment,the anatomical features of the body region are fairly uniform, e.g., theanatomical features of the upper thigh, and as such the arrangement ofthe one or more illuminated injection sites can be more generalized orless specific to the individual.

In one embodiment, an injection-treatment plan including aninjection-treatment pattern of one or more illuminated injection sitesis developed for the specific needs of an individual. In the case of aninjection-treatment plan designed for use on the face of an individualfor cosmetic use, for example, the arrangement of the one or moreilluminated injection sites can include situating the one or moreilluminated injection sites over, for example, one or more lines,wrinkles, folds, or pouches in need of treatment on the individual'sface. In one embodiment, the one or more illuminated injection sites aresituated over one or more horizontal forehead lines, glabellar frownlines, periorbital lines, preauricular lines, cheek lines, nasolabialfolds, upper radial lip lines, lower radial lip lines, corner of themouth lines, marionette lines, labiomental crease, and/or horizontalneck folds.

In one embodiment, an injection-treatment plan designed for use on theface of an individual can include an injection-treatment pattern of oneor more illuminated injection sites situated over one or more musclesassociated with creating lines and wrinkles on the individual's face.For example, the one or more illuminated injection sites can be situatedover the occipito-frontalis muscle of the forehead for treatment ofhorizontal forehead wrinkles; the procerus muscle between the eyebrowsfor treatment of horizontal wrinkling above the bridge of the nose; thecorrugators muscle for treatment of the wrinkles that appear between theeyebrows; the orbicularis oculi muscles around the eyes for thetreatment of “crow's feet;” the nasalis muscles of the nose for thetreatment of “bunny lines” along the side of the nose; the orbicularisoris muscles around the lips for the treatment of radial pucker lines onthe lips; and the depressor anguli oris muscles under the lips.

In one embodiment, the injection-treatment plan can include aninjection-treatment pattern of one or more illuminated injection sitesarranged in such a way as to create volume upon injection of a fillersubstance. For example, a series of illuminated injection sites can bearranged in a linear treatment pattern along a skin fold. In anotherexample, the one or more illuminated injection sites can be arranged ina square injection pattern to facilitate threading of an injectableagent in a crisscross pattern.

In one embodiment, an injection-treatment plan can include aninjection-treatment pattern of one or more illuminated injection sitesarranged so as to avoid portions of the underlying tissue of the bodyregion that might be contraindicated for administration of an injectableagent. For example, the one or more illuminated injection sites may bearranged so as to avoid injection of an injectable agent into anunderlying blood vessel. Other non-limiting examples of contraindicatedinjection sites include areas of infection, skin disease or inflammation(unless the injectable agent is being used to treat said conditions) orareas too close to the orbits (to prevent ptosis).

Returning to FIG. 3, block 360 illustrates that computing device 340 isoperable to control the one or more controllable light-emitting elementsto illuminate a location on a surface of the body region of theindividual corresponding in location to at least one of the one or moredigitally registered injection sites. For example, the computing devicemay be operable to control an on/off function and/or position of one ormore controllable light-emitting elements to direct illumination on thesurface of the body region to a location corresponding to one or moreinjection sites. For example, the computing device may be operable tocontrol sequencing of an array of controllable light-emitting elementssuch that each of the one or more controllable light-emitting elementsin the array are sequentially turned on or off according to aninjection-treatment pattern.

Block 360 includes optional blocks 362, 364, 366, 368, and 369. Block362 illustrates computing device 340 optionally operable to control oneor more of an on/off function, position, intensity, focus, color ofemitted light, or pattern of emitted light of the one or morecontrollable light-emitting elements. Block 364 illustrates computingdevice 340 optionally operable to dynamically control one or more of anon/off function, position, intensity, focus, color of emitted light, orpattern of emitted light of the one or more controllable light-emittingelements before, during, or after injection at one or more illuminatedinjection sites. For example, the computing device may be operable tochange the color of an illuminated injection site, e.g., from green tored, once injection has occurred at said illuminated injection site.Block 366 illustrates computing device 340 optionally operable tocontrol the one or more controllable light-emitting elements toilluminate the surface of the body region in at least one of a spatialor temporal sequence of illumination. For example, the one or morecontrollable light-emitting elements may be turned on/off in a spatialor temporal sequence to illuminate a single location on the surface ofthe body region at any given time. For example, the location of anygiven illuminated injection site may move over the surface of the bodyregion before or after an injection is completed at a previouslyinjected illuminated injection site. In one embodiment, the sequence ofillumination is indicative of future injection sites, e.g., illuminatingthe injection sites that need to be injected next. In one embodiment,the sequence of illumination is indicative of success at a previousinjection site, e.g., illuminating the injection sites that have beensuccessfully injected. Block 368 illustrates computing device 340optionally operable to control at least one of a spatial or temporalsequence of at least one of a color or pattern of light emitted from theone or more controllable light-emitting elements. Block 369 illustratescomputing device 340 optionally operable to control the one or morecontrollable light-emitting elements to illuminate a location on asurface of the body region of the individual corresponding in size to atleast one of the one or more digitally registered injection sites.

FIG. 3 illustrates further embodiments of computing device 340. Block370 illustrates that computing device 340 is optionally operable tocontrol the one or more controllable light-emitting elements to projectone or more pieces of information or annotations onto the surface of thebody region. For examples, the one or more pieces of information caninclude one or more pieces of information projected on the surface ofthe body region to instruct a user, e.g., a physician, practitioner orother user, as to the injection-treatment pattern or injection-treatmentplan. In one embodiment, the one or more pieces of information areprojected at or near one or more illuminated injection sites. The one ormore pieces of information can be represented by one or more letters,numbers, shapes, text, symbols, colors, or combinations thereof. In oneembodiment, the one or more pieces of information can include one ormore treatment parameters. For example, the one or more pieces ofinformation projected onto the surface of the body region may includetext describing the injectable agent, e.g., a neurotoxin, and the dosageof said injectable agent, e.g., units per injection, to be used at agiven illuminated injection site. In one embodiment, the one or morepieces of information can include one or more injection status updates,the one or more injection status updates including, but not limited to,one or more of a running clock, a number of injections completed, anumber of injections remaining, or a status of alignment of one or moreilluminated injection sites with the one or more physical registrationlandmarks on the body region. For example, a running clock may beprojected onto the surface of the body region, e.g., on the surface ofthe individual's forehead, to inform the physician or other practitioneras to how much time has expired between injections or over the course ofan injection treatment session. For example, the number of injectionscompleted and/or the number of injections still needed to be performedmay be projected onto the surface of the body region to inform the user,e.g., a physician or other practitioner, as to how well the injectiontreatment session is progressing.

Block 375 illustrates that computing device 340 is optionally operableto receive one or more digital images of the body region including theone or more physical registration landmarks and one or more illuminatedinjection sites on the body region from at least one image capturedevice 395; and adjust the one or more controllable light-emittingelements 310 so as to align the one or more illuminated injection sitesrelative to the one or more physical registration landmarks on the bodyregion to substantially correspond to the at least one digitalrepresentation of the body region. In one embodiment, the computingdevice is operable to align the one or more digital images of the bodyregion including the one or more physical registration landmarks and theone or more illuminated injection sites with the digital representationof the body region including one or more digital registration landmarksand one or more digitally registered injection sites using one or moreof an image registration algorithm. In general, the computing device isoperable to detect features depicted in the digital images, e.g., thephysical registration landmarks, and match these features with featuresin the digital representation, e.g., the digital registration landmarks.Features and the relationships between them may be detected using any ofa number of feature-based methods including, but not limited to,segmentation methods, distance transform, affinely invariantneighborhoods, Harris corner detection, Maximally Stable ExternalRegions, Canny detector, Laplacian of Gaussian, elastic contourextraction, existing edge detection, line intersections, local extremaof wavelet transform, inflection points of curves, and the like. Thecomputing device is further operable to match the features detected inthe one or more images of the body region with features in the digitalrepresentation of the body region using one or more feature-matchingmethods, non-limiting examples of which include Euclidean distancematching, invariant moments, nearest neighbor based matching,correlation-like methods, Fourier methods, mutual information methods,optimization methods. Further non-limiting examples include methodsusing spatial relations, e.g., graph matching algorithms, methods usinginvariant descriptors, and relaxation methods. The following referencesare incorporated by reference and include descriptions of computationalmethods for image registration: Szeliski Foundations and Trends inComputer Graphics and Vision, Vol. 2, No. 1 (2006) 1-104, Zitova &Flusser Image Vision Computing (2003) 21:977-1000. The computing deviceis operable to adjust the one or more light-emitting elements to keepthe components of the digital images, i.e., the one or more physicalregistration landmarks and the one or more illuminated injections sites,aligned with the components of digital representation, i.e., the one ormore digital registration landmarks and the one or more digitallyregistered injection sites. In one embodiment, adjusting the one or morelight-emitting elements can include instructing the one or morelight-emitting elements to move so as to change the location of theilluminated injection site on the surface of the body region. In oneembodiment, adjusting the one or more light-emitting elements caninclude instructing the one or more light-emitting elements in an arrayto turn on or off so as to change the location of the illuminatedinjection site on the surface of the body region.

Block 380 illustrates that computing device 340 is optionally operableto control the one or more controllable light-emitting elementsconfigured to emit non-destructive light to illuminate a location on thesurface of the body region of the individual corresponding in locationto at least one of the one or more digitally registered injection sitesbased on registration of the one or more digitally registered injectionsites with the one or more digital registration landmarks correspondingto the one or more physical registration landmarks on the body region.

Block 385 illustrates that computing device 340 is optionally operableto record to one or more data storage devices information regarding aninjection treatment session including at least one of one or moreinjections given at one or more illuminated injection sites, a type ofinjectable agent, a dosage of an injectable agent, a type of injector, asequence of injections, a timing of injection, an injection depth, or aninjection angle, the length of the injection treatment session, atreatment outcome, and any adverse reactions associated with theinjection treatment session.

Block 390 illustrates that computing device 340 is optionally operableto receive one or more digital images of the body region including oneor more physical registration landmarks from at least one image capturedevice; generate at least one digital representation of the body regionusing the one or more digital images, the at least one digitalrepresentation including one or more digital registration landmarkscorresponding to the one or more physical registration landmarks on thebody region; generate an injection-treatment plan based on analysis ofthe at least one digital representation of the body region; and add oneor more digitally registered injection sites to the at least one digitalrepresentation of the body region, the one or more digitally registeredinjection sites registered relative to the one or more digitalregistration landmarks.

Returning to FIG. 3, system 300 further optionally includes imagecapture device 395. In one embodiment, image capture device 395 isconfigured to acquire one or more digital images of body region 320including the one or more physical registration landmarks andilluminated injection site 330 on the surface of body region 320 ofindividual 325. In one embodiment, image capture device 395 can be usedto provide real-time feedback as to the registration of the illuminatedinjection sites relative to the one or more physical registrationlandmarks in accordance with the at least one digital representation ofthe body region. In one embodiment, image capture device 395 isconfigured to capture an image of an injector relative to an illuminatedinjection site to assist in accurate placement of the injector. In oneembodiment, image capture device 395 is configured to documentsuccessful or erroneous injection of an injectable agent at a givenilluminated injection site. In one embodiment, image capture device 395is configured to acquire one or more digital images used to generate theat least one digital representation of the body region of theindividual.

Image capture device 395 can include one or more passive or activescanners, digital cameras, charge-coupled device (CCD), complementarymetal oxide semiconductor (CMOS), infrared sensor, or any other devicesuited to capturing an image of a body region. Other non-limitingexamples of an image capture device include an ultrasound device, aphotoacoustic device, a thermal imaging device, a contact scanningdevice, a non-contact scanning device, a magnetic resonance imagingdevice, a computed tomography device, a capacitance measuring device, anelectomyographic device, or other biomedical imaging devices. Imagecapture device 395 is further configured to transmit one or more outputsignals having information associated with the one or more digitalimages to computing device 395 through one or more wired or wirelesstransmissions.

FIG. 4 illustrates further embodiments of a system for guidinginjection. In one embodiment, as illustrated in flow diagram 400, thecomputing device of the system is operable to register a position of aninjector relative to an illuminated injection site at step 410. Theposition of an injector may be registered based on analysis of one ormore digital images that include the injector and an illuminatedinjection site. Alternatively, the injector may include a sensor, e.g.,a photo-sensor, which is activated when the injector is in the path ofthe light beam illuminating the injection site. The computing device isoperable to determine whether the injector and illuminated injectionsites are coincident at step 420. If the injector and the illuminatedinjection site are coincident at step 430, then a message is sent toproceed with injection at step 450. The message can be an audio, visual,or haptic message. The computing device is then operable to record oneor more injection events at the illuminated injection site at step 460.If the injector and the illuminated injection site are not coincident atstep 440, then the computing device is operable to issue an alarm atstep 470. The alarm can be an audio, visual, haptic alarm. In oneembodiment, the alarm can include haptic feedback. In response, the usermoves the injector at step 480, and the computing device again registersthe position of the injector relative to the illuminated injection site410.

In one embodiment, a system for guiding injection includes at least twoor more controllable light-emitting elements configured to emitnon-destructive light and positioned to illuminate an injection site ona body region of an individual from two or more angles or positionsrelative to the surface of the body region. Two or more controllablelight-emitting elements positioned at two or more angles are used toensure that at least one beam of light from the two or more controllablelight-emitting elements is able to reach the intended injection site.For example, in a treatment room containing two or more controllablelight-emitting elements located so as to emit light onto the surface ofa body region of an individual, it is conceivable that the user, e.g. aphysician or other practitioner, will inadvertently block one or morebeams of emitted light in the process of trying to place a needle of aninjector at or near an illuminated injection site. In one embodiment,the computing device of the system is operable to selectively turn onand/or off one or more of the two or more controllable light-emittingelements depending upon whether a light beam is broken to ensure that atleast one of the two or more controllable light-emitting elements isilluminating the one or more injection sites. FIG. 5 illustrates anembodiment of a system for illuminating an injection site with twocontrollable light-emitting elements. System 500 includes firstcontrollable light-emitting element 510 and second controllablelight-emitting element 515. First controllable light-emitting element510 emits beam 520 to illuminate injection site 530 on body region 535.Second controllable light-emitting element 515 emits beam 525 to alsoilluminate injection site 530 on body region 535. Illuminated injectionsite 530 is a target of injection by injector 540. System 500 furtherincludes computing device 545 operable to receive one or more digitalrepresentations of body region 535 of an individual and to control firstcontrollable light-emitting element 510 and second controllablelight-emitting element 515.

System 500 optionally includes image capture device 550. In oneembodiment, image capture device 550 is configured to capture one ormore images of the body region of an individual, including one or moreilluminated injection sites and an injector, to monitor registration ofthe illuminated injection sites and proper placement of the injector. Inone embodiment, image capture device 550 is also configured to captureone or more images of a body region for use in developing at digitalrepresentation of the body region.

In one embodiment, all or part of a system for guiding injection of anindividual are incorporated into a treatment room of a physician'soffice or of a clinic. In one embodiment, all or part of a system forguiding injection of an individual are incorporated into an individual'shome. In one embodiment, all or part of the system is incorporated intoa piece of furniture, e.g., a chair, table, or bed. In one embodiment,all or part of the system is incorporated into the walls or otherstructural features of a room. In one embodiment, all or part of thesystem is free-standing.

In one embodiment, all or part of a system for guiding injection of anindividual is mounted on the head of a user. FIGS. 6A, 6B, and 6Cillustrate embodiments of a system mounted on the head of a user forguiding injection of an injectable agent into a body region of anindividual. In an embodiment, as illustrated in FIG. 6A, system 600 canbe mounted on a head region of user 605. In one embodiment, user 605 isa physician or other practitioner who is carrying out the injections inaccordance with an injection-treatment plan. In one embodiment, the useris the individual who uses the head-mounted system for guidingself-injection onto an accessible body region, e.g., lower abdomen orupper thigh, as illustrated in FIG. 6C. System 600 is mounted to headregion of a user 605 with head encircling piece 610. In one embodiment,system 600 may be incorporated into a helmet or hat-like structure. Inone embodiment, system 600 may be incorporated into a device worn overthe eyes, e.g., a pair of glasses. As illustrated in FIG. 6B, system 600includes one or more controllable light-emitting elements 640 (e.g., oneor more laser diodes or LEDs), optionally at least one image capturedevice 345 (e.g., a camera), and a computing device including aprocessor 650. One or more controllable light-emitting elements 640 ofsystem 600 emits beam of light 615 onto the surface of a body region ofan individual 625. Beam of light 615 illuminates injection site 620,which in turn becomes a target for injection by injector 630.

System 600 further includes transmission unit 655 and antenna 660configured to receive and transmit input/output signals. For example,transmitter unit 655 and antenna 660 may be configured to receive inputsignals having information regarding at least one digital representationof a body region of an individual. In one embodiment, transmission unit655 is directly connected to head-mounted computing device 640. In oneembodiment, transmission unit 655 has its own processor that is operablyconnected to computing device 640. In one embodiment, all or part ofcomputing device 650 may be in a location remote from the controllablelight-emitting elements mounted on the head region of an individual. Assuch, transmitter unit 655 and antenna 660 may be configured to receiveinput signals from the remote computing device having information forcontrolling the one or more controllable light-emitting elements.Similarly, transmission unit 655 and antenna 660 may be configured tosend output signals having information regarding one or more digitalimages captured by the at least one image capture device mounted on thehead region of the individual.

A “transmission unit,” as used herein, can be one or more of a varietyof units that are configured to send and/or receive signals, such assignals carried as electromagnetic waves. A transmission unit generallyincludes at least one antenna and associated circuitry. A transmissionunit can include a transmitter and a receiver. A transmission unit caninclude volatile or non-volatile memory. A transmission unit can includea processor and/or be operably connected to a processor. A transmissionunit can be operably connected to an energy source, such as a battery. Atransmission unit can include an energy harvesting unit, such as a unitconfigured to obtain energy from electromagnetic waves. A transmissionunit can include a transponder utilizing electromagnetic waves, forexample as described in “Fundamental Operating Principles,” in Chapter 3of the RFID Handbook: Fundamentals and Applications in Contactless SmartCards and Identification, Klaus Finkenzeller, John Wiley & Sons, (2003),which is incorporated herein by reference. A transmission unit caninclude an oscillator and encoder configured to generate a programmablepulse position-modulated signal in the radio frequency range (see, e.g.,U.S. Pat. No. 4,384,288, which is incorporated herein by reference). Atransmission unit can include a radio frequency identification device(RFID), which can be a passive RFID device, a semi-passive RFID device,or an active RFID device, depending on the embodiment (see, e.g., Chawla& Ha, “An Overview of Passive RFID,” IEEE Applications and Practice,11-17 (September 2007), which is incorporated herein by reference). Atransmission unit including an RFID device can be configured to transmitsignals in the UHF standard range. A transmission unit can include abattery-assisted passive RFID device, such as sold by Alien Technology®,Morgan Hill, Calif. A transmission unit can include an opticaltransmission unit. A transmission unit can include a hybrid backscattersystem configured to function in an RFID, IEEE 802.11x standard andBluetooth system (see, e.g., U.S. Pat. No. 7,215,976, which isincorporated herein by reference). A transmission unit can include anear field communication (NFC) device. A transmission unit can include aWireless Identification and Sensing Platform (WISP) device. Atransmission unit can be operably coupled to a data storage unit, forexample as described in U.S. Pat. No. 7,825,776 and US PatentApplication No. 2009/0243813, which are each incorporated herein byreference.

System 600 further includes battery 662 for providing power to thevarious components of the system. For example, battery 662 can include acamera or watch sized alkaline, lithium, or silver-oxide battery orother appropriately sized and powered battery.

FIG. 6C shows system 600 for use in guiding self-injection of aninjectable agent. In this example, individual 665 is performingself-injection on body region 680, e.g., the upper leg of individual665. One or more controllable light-emitting elements 640 incorporatedinto system 600 emit beam of light 670 to illuminate injection site 675on the surface of body region 680.

In one embodiment, the one or more injection sites are illuminated onthe surface of the body region of an individual in a sequential patternin accordance with an injection-treatment plan. In an embodiment, thefirst illuminated injection site is injected first, and after successfulcompletion of the first injection, a second illuminated injection sitebecomes visible and ready for the second injection. In one embodiment,the first illuminated injection site remains or changes in property,e.g., color or pattern, to indicate that a successful injection hasalready occurred at this site. In one embodiment, each injection site isilluminated one at a time in a sequence. FIGS. 7A-C illustrate anembodiment of a system for guiding injection in an individual mounted ona user's head in which each injection site is illuminated sequentiallyunder control of the computing device. FIGS. 7A-C further illustrate thesteps of sequentially illuminating different injection sites over time.FIG. 7A shows system 700 mounted on a head region of a user 710. One ormore controllable light-emitting elements associated with system 700emit first light beam 720. First light beam 720 illuminates firstinjection site 730 on the surface of body region 740 of an individual.FIG. 7B shows system 700 emitting second light beam 760 and illuminatingsecond injection site 770 on body region 740 of the individual. FIG. 7Cshows system 700 emitting third light beam 780 and illuminating thirdinjection site 790 on body region 740 of the individual. In this way,each injection site is illuminated at a location and in sequencerespectively dictated by the digital representation of the body regionand associated digitally registered injection sites and theinjection-treatment pattern and/or the injection-treatment plan. In oneembodiment, the sequencing can be contingent on completing injection ata previously illuminated injection site. For example, system 700 mayinclude a feedback system, e.g., an image capture device, whichdocuments injection at a first illuminated injection site and does notilluminate a second injection site until the injection at the firstilluminated injection site is successfully completed. It is furthercontemplated that the system for sequentially guiding injection in anindividual in which each injection site is illuminated sequentially canbe positioned relative to the individual in a location that is notnecessarily mounted on the head of a user.

In one embodiment, a system for guiding an injection in an individualincludes a computing device operable to control the one or morecontrollable light-emitting elements to project one or more pieces ofinformation or annotation onto a surface of a body region of anindividual, as illustrated in FIG. 3. In one embodiment, the one or morepieces of information are projected at or near one or more illuminatedinjection sites. However, it is contemplated that one or more pieces ofinformation can be projected anywhere on the surface of the body regionregardless of the location of the one or more illuminated injectionsites. The one or more pieces of information can be represented by oneor more letters, numbers, shapes, symbols, text, color, or combinationsthereof. The one or more pieces of information can include one or moretreatment parameters and/or one or more injection status updates.

FIG. 8 illustrates an embodiment of a system for guiding an injectioninto an individual that includes one or more controllable light-emittingelements configured to project one or more pieces of information as wellas illuminate one or more injection sites on the surface of a bodyregion of an individual. System 800 includes controllable light-emittingelement 810 operably connected to computing device 820 through wired orwireless transmission means 815. Controllable light-emitting element 810emits a beam of light 830 that illuminates injection sites 850 on thesurface of body region 840. In one embodiment, as illustrated in FIG. 8,more than one injection site can be illuminated simultaneously.Controllable light-emitting element 810 also projects pieces ofinformation 860, e.g., numbers, onto the surface of body region 840indicating a treatment parameter, e.g., an order in which injections atilluminated injection sites 850 should be carried out. In thisparticular example, each projected piece of information, e.g., a numberfrom 1-5, is projected near an illuminated injection site. Controllablelight-emitting element 810 also projects pieces of information 880,e.g., an injection status update in the form of a running clock, at alocation distinct from the illuminated injection sites. In oneembodiment, the at least one digital representation 870 of body region840 (shown on the monitor of computing device 820 and on the face of theindividual as dotted lines) may also be projected onto the surface ofthe same said body region, the digital registration landmarks of the atleast one digital representation aligning with the physical registrationlandmarks, e.g., anatomical features such as the nose, eyes, and eyebrows as illustrated in FIG. 8. In one embodiment, the one or morepieces of information may be projected in a sequence to coincide withsequential illumination of one or more injection sites on the surface ofthe body region. System 800 can optionally include image capture device890 for acquiring one or more digital images of the body region toprovide feedback during the injection-treatment session. Image capturedevice 890 is operably connected to computing device 820 through wiredor wireless transmission means 895.

In one embodiment, each of the illuminated injection sites is annotatedwith one or more pieces of information projected from the controllablelight-emitting element. In one embodiment, only a subset of theilluminated injection sites are annotated with one or more pieces ofinformation projected from the controllable light-emitting element. Inone embodiment, the one or more pieces of information projected from thecontrollable light-emitting element are generic and appropriate for usefor any individual undergoing treatment for a specific condition. In oneembodiment, the one or more pieces of information projected from thecontrollable light-emitting element are specific to an individual forwhom an injection-treatment plan has been designed. For example, thetype of injectable agent and/or dosage used may be based on the specificcondition of the individual as well as other criteria, e.g., weight,age, skin thickness, allergic response, or other physiological criteriarelevant to administration of an injectable agent.

In an embodiment, the one or more pieces of information 860 projectedfrom the controllable light-emitting element are indicative of at leastone type of injectable agent to be injected at at least one of the oneor more illuminated injection sites. For example, a cosmetic treatmentof the face can include one or more pieces of information annotating oneor more illuminated injection sites for treating a facial region with atleast one injectable agent, e.g., a neurotoxin, subcutaneous volumeenhancer, or dermal filler (see, e.g., Carruthers et al., Plast.Reconstr. Surg. (2008) 121 (Suppl):5S-30S, which is incorporated hereinby reference). Non-limiting examples of other injectable agents includeinsulin, antibiotics, hormones, chemotherapeutics or biological agents.In an embodiment, the one or more pieces of information 860 projectedfrom the controllable light-emitting element are indicative of at leastone dosage of at least one injectable agent to be injected at at leastone of the one or more illuminated injection sites. The dosage of theinjectable agent can include one or more units or parts thereof, one ormore milliliters or parts thereof, or one or more other measures ofdosage. For example, the neurotoxin onabotulinumtoxinA (BOTOX®) istypically injected in 3-5 unit increments per injection. The dosage canalso include timing and sequence of injection of the injectable agent.For example, an injectable agent may be injected over a prescribedperiod of time, e.g., quickly or slowly. For example, a needle of aninjector may be left penetrating the injection site for a prescribedperiod of time. For example, an injectable agent may be injectedmultiple times over the course of hours, days, or weeks. For example, aninjection-treatment plan may include two or more injectable agents andeach of two or more injectable agents may be injected in a preferred orprescribed sequence.

In one embodiment, the one or more pieces of information 860 projectedfrom the one or more controllable light-emitting elements are indicativeof at least one needle injection depth of at least one type ofinjectable agent to be injected at at least one of the one or moreilluminated injection sites. In one embodiment, the one or more needleinjection depth is dependent upon the length of the injection needle.The length of the injection needle can be measured in inches ormillimeters (mm). In one embodiment, the length of the injection needlecan vary from about 4 mm ( 5/32 inches) to about 12.7 mm (½ inches).Injection needles of shorter or longer length, e.g., up to about 50 mm(2 inches) or more can also be contemplated for injection at the one ormore illuminated injection sites.

In one embodiment, the one or more pieces of information include aninjection angle. The angle at which one or more injection needles areinjected at the one or more illuminated injection sites can be dependenton the injectable agent and the desired depth of the needle injectioninto the underlying tissue of the body region of the individual and thedesired pattern of injection. For example, injections into the muscle,i.e., intramuscular injection, may be done with an injection needle at a90 degree angle; injections into the subcutis, i.e, subcutaneousinjection, may be done with an injection needle at a 45 degree angle;and injections into the epidermis or dermis may be done with aninjection needle at a 10 to 15 degree angle.

The systems and methods described herein for guiding injection into anindividual with one or more illuminated injection sites can beimplemented on any of a number of body regions including, but notlimited to the face, the torso, the abdomen, the neck, the head, theupper extremities, the lower extremities, the buttocks, or any otherbody region of the individual accessible to injection.

In one embodiment, the systems and methods described herein are used bya physician or other practitioner to guide injection of injectableagents into a patient. In one embodiment, the systems and methoddescribed herein are used by an individual to guide self-injection of aninjectable agent. Non-limiting examples of injectable agents forself-injection include antibiotics, insulin, fertility hormones (e.g.,FSH, ganirelix, cetrotide, Lupron, HCG), immunomodulators (e.g.,etanercept), glatiramer (injected daily to treat multiple sclerosis),teriparatide (injected daily to treat osteoporosis), enoxaparin(injected daily to treat deep vein thrombosis), vitamins (e.g., vitaminB12).

In one embodiment, a system for guiding injection into an individualincludes an injector-tracking device. The injector-tracking device issized for attachment to an injector and includes at least one alertcomponent and one or more photo-sensors. FIG. 9A illustrates anembodiment of a system including an injector-tracking device. System 900includes at least one controllable light-emitting element 910 operablyconnected to computing device 940. The at least one controllablelight-emitting element 910 emits light 915 to illuminate injection site930 on body region 920 of individual 925. Injector 935 includesinjector-tracking device 945 attached to the shaft of the injectionneedle associated with injector 935. Injector-tracking device 945associated with injector 935 includes one or more photo-sensors. Wheninjector 935 and associated injector-tracking device 945 come close tothe illuminated injection site, e.g., cross in the path of light 915,the one or more photo-sensors are activated.

FIG. 9B illustrates further aspects of an injector-tracking device sizedfor attachment to an injector. Injector-tracking device 945 can includeone or more photo-sensors 950. The one or more photo-sensors 950 areoperably connected to microprocessor 955 configured to receive one ormore signals from the one or more photo-sensors 950 and activate alertcomponent 960. Alert component 960 is configured to output an alert inresponse to activation of the one or more photo-sensors 950. Alertcomponent 960 can further include one or more of an audible alertcomponent 965, an optical alert component 970, a haptic alert component975, and/or a wireless alert component 980. In one embodiment, theinjector-tracking device includes a processor operable to calculate adistance between the tip of the injector, e.g., the tip of a needleattached to the injector, and the surface of skin at the illuminatedinjection site.

The injector-tracking device is sized for attachment to an injector. Inone embodiment, the injector-tracking device is sized for attachment tothe needle shaft of an injector. In one embodiment, theinjector-tracking device is sized for attachment to the needle hub or aportion of the syringe attached to the injector. In one embodiment, theinjector-tracking device is permanently attached to the injector. In oneembodiment, the injector-tracking device is removable, allowing for useon more than one injector. The injector-tracking device may be attachedto the injector through one or more of a strap, an adhesive, a sleeve, aclamp, or a clip.

Injector-tracking device 945 includes one or more photo-sensors 950configured to detect light associated with the one or more illuminatedinjection sites. The one or more photo-sensors can include one or morecomplementary metal-oxide-semiconductor (CMOS) sensors, charge coupleddevice (CCD) sensors, photodiodes, photoresistors, photovoltaic cells,photomultiplier, phototransistors, or quantum dot photoconductors.Photo-sensors are available from a variety of commercial sources (from,e.g., Hamamatsu Photonics, Japan; Advanced Photonix, Inc., Ann Arbor,Mich.; OSI Optoelectronics, Hawthorne, Calif.).

In one embodiment, the alert component of the injector-tracking deviceincludes an audible alert component. The audible alert componentincludes a speaker for emitting an audible alert. FIGS. 10A and 10Billustrate an embodiment of a system including an injector-trackingdevice with an audible alert component. In FIG. 10A, injector-trackingdevice 1000 is attached to injector 1010, in this instance toward theend of needle shaft 1015. Controllable light-emitting element 1020 emitslight 1030 to illuminate injection site 1040. Injector-tracking device1000 is outside light 1030 and not emitting any sound. In FIG. 10B,injector-tracking device 1000 has moved into light 1030 and now emits anaudible alert. In one embodiment, the audible alert component is turnedon and issues a sound audible to the user when the injector-trackingdevice has come in appropriate contact with an illuminated injectionsite. For example, the injector-tracking device may not emit any audiblesound until the injector is in the appropriate location, as illustratedin the embodiment of FIG. 10. In one embodiment, the audible alertcomponent changes the tone, frequency, or volume of a continuouslyemitted sound audible to the user when the injector-tracking devicecomes in appropriate contact with an illuminated injection site. Forexample, the injector-tracking device may emit a constant beeping sound,the beeping sound changing in quality, e.g., tone, frequency, or volume,when the injector-tracking device and consequently the associatedinjector is in the appropriate location. The audible alert component caninclude one or more of a sound chip, sound card, or a microchip. In oneembodiment, the audible alert component can include a piezoelectricspeaker. A variety of suitable piezoelectric speakers are available,including from Murata Manufacturing Co., Ltd., (Smyra, Ga.). In oneembodiment, an audible alert component can include a piezoelectricspeaker configured to generate a beeping noise in response to a signalfrom the processor and/or photo-sensor.

In one embodiment, the alert component includes an optical alertcomponent. The optical alert component includes one or more elementsthat emit light. FIGS. 11A and 11B illustrate an embodiment of a systemincluding an injector-tracking device with an optical alert component.In FIG. 11A, injector-tracking device 1100 is attached to injector 1110,in this instance toward the end of needle shaft 1115. Controllablelight-emitting element 1120 emits light 1130 to illuminate injectionsite 1140. Injector-tracking device 1100 is outside light 1130 and notemitting any optical alert, e.g., visible light. In FIG. 11B,injector-tracking device 1100 has moved into light 1130 and now emits anoptical alert. In one embodiment, the optical alert component is turnedon and emits light visible to the user when the injector-tracking devicehas come in appropriate contact with an illuminated injection site. Forexample, the injector-tracking device may not emit light until theinjector is in the appropriate location. In one embodiment, the opticalalert component changes a color, continuity, or brightness of acontinuously or intermittently emitted light when the injector-trackingdevice comes in appropriate contact with an illuminated injection site.For example, the injector-tracking device may emit a flashing opticalsignal which changes to continuous emission when the injector-trackingdevice and consequently the associated injector is in the appropriatelocation. For example, the injector-tracking device may emit a firstcolor of light, e.g., red light, which changes to a second color oflight, e.g., green light, when the injector is in the appropriatelocation based on detection of the illuminated injection site by the oneor more photo-sensors on the injector-tracking device. Examples of lightsources for use in an optical alert component include controllablelight-emitting diodes, quantum dots, laser diodes, or other relativelysmall light sources.

In one embodiment, the alert component is a wireless alert component,capable of transmitting a wireless transmission to a receiver. In oneembodiment, the alert component includes a transmission unit,non-limiting components of which have been described herein. In oneembodiment, the wireless alert component sends a wireless transmissionback to the computing device of the system. The computing device in turnmay change the quality of the light emitted from the controllablelight-emitting elements to indicate that an injection has beensuccessfully completed at a given spot. For example, the color orpattern of light illuminating an injection site may change in responseto a wireless signal from the injector-tracking device. In oneembodiment, the wireless alert component sends a wireless transmissionback to another device, e.g., a head-set, a hand-held device, anear-piece, a display, or other device capable of receiving a wirelesstransmission and sending an audible or visible alert to the user.

FIG. 12 illustrates a method for guiding injection in an individual.Block 1200 shows illuminating one or more injection sites in aninjection-treatment pattern on a surface of a body region of theindividual. Illuminating one or more injection sites in aninjection-treatment pattern on a specific body region of the individualis dependent upon the condition being treated and theinjection-treatment plan. For example, specific treatment of theindividual's face or the individual's neck would necessitateilluminating one or more injection sites in an injection-treatmentpattern on a face or neck, respectively. In another example, aself-injection injection-treatment plan that includes intramuscularinjections, e.g., antibiotic or fertility treatment, may includeilluminating one or more injection sites on any of a number of bodyregions easily accessible to the individual, e.g., the thigh or abdomenareas. Block 1210 of FIG. 12 depicts injecting at least one injectableagent into an underlying tissue of the body region of the individual ator near at least one of the one or more illuminated injection sites. Theone or more injection sites can be illuminated by one or morecontrollable light-emitting elements configured to emit non-destructivelight, the one or more controllable light-emitting elements controlledby a computing device including a process as described herein.

FIG. 13 depicts further aspects of the method illustrated in FIG. 12 forguiding injection in an individual. FIG. 13 includes block 1300. Block1300 shows optionally illuminating the one or more injection sites onthe surface of a face, torso, abdomen, head, neck, upper extremity,lower extremity, or buttocks region of an individual. In general,injection sites may be illuminated on any portion of the body accessibleto injection by a user, e.g., a physician or other practitioner, or theindividual in the case of self-injection.

FIG. 13 further includes block 1310. Block 1310 depicts optionallyilluminating the one or more injection sites on the surface of the bodyregion of the individual with one or more controllable light-emittingelements configured to emit non-destructive light. Block 1310 furtherincludes optional block 1320. Block 1320 depicts optionally illuminatingthe one or more injection sites on the surface of the body region of theindividual with one or more of a controllable light-emitting diode,laser, laser diode, collimated light source, projector, or focused lightsource configured to emit non-destructive light. Non-limiting examplesof controllable light-emitting elements have been described aboveherein.

FIG. 13 further includes block 1330. Block 1330 depicts optionallyilluminating the one or more injection sites on the surface of the bodyregion of the individual with one or more controllable light-emittingelements mounted on a head region of the user, the one or morecontrollable light-emitting elements configured to emit non-destructivelight. In one embodiment, the user is a physician or other practitionerperforming injection on an individual. In one embodiment, the user is anindividual performing self-injection. Embodiments of a system forilluminating injection sites using controllable light-emitting elementsmounted on a head region of a user have been described above herein andan embodiment illustrated in FIG. 6.

FIG. 13 further includes block 1340. Block 1340 shows optionallyautonomously illuminating the one or more injection sites using acomputing device operably connected to one or more controllablelight-emitting elements, the computing device accessing a storedinjection-treatment plan and controlling illumination from the one ormore controllable light-emitting elements to illuminate the one or moreinjection sites on the surface of the body region of the individual inaccordance with the stored injection-treatment plan. In one embodiment,the injection-treatment plan is specific to the individual. In oneembodiment, the injection-treatment plan is specific to a conditionbeing treated.

FIG. 14 depicts further aspects of the method illustrated in FIG. 12 forguiding injection in an individual. FIG. 14 includes block 1400. Block1400 depicts optionally illuminating the one or more injection sites onthe surface of the body region of the individual with one or more of acolor or pattern of light. Block 1400 further includes blocks 1410 and1420. Block 1410 shows optionally illuminating the one or more injectionsites on the surface of the body region of the individual with one ormore of a crosshair, ring, circle, or concentric circles. Block 1420shows optionally illuminating the one or more injection sites on thesurface of the body region of the individual with one or more of aletter, number, symbol, or shape. Methods for illuminating a surfacewith a pattern of light include using diffusers, filters, and/orprojected images have been described above herein.

FIG. 14 further includes optional block 1430. Block 1430 depicts whereinthe one or more of the color or pattern of light is representative of atleast one injection-treatment parameter. Block 1430 further includesoptional block 1440. Block 1440 depicts wherein the at least oneinjection-treatment parameter comprises at least one of an injectionsite, a type of injectable agent, a type of injector, a dosage of aninjectable agent, a sequence of dosing an injectable agent, a timing ofdosing an injectable agent, an injection depth, or an injection angle.

FIG. 15 shows further aspects of the method of FIG. 12 for guidinginjection in an individual. FIG. 15 includes block 1500. Block 1500depicts optionally illuminating the one or more projected injectionsites in the injection-treatment pattern simultaneously on the surfaceof the body region of the individual. In one embodiment, all of the oneor more injection sites are illuminated at the same time. In oneembodiment, each injection site is illuminated with light emitted from asingle controllable light-emitting element. In one embodiment, all ofthe one or more injection sites are illuminated simultaneously withlight emitted from a projector, projecting an image onto the bodysurface that includes the entirety of the illuminated injection sites.FIG. 15 further includes block 1510. Block 1510 depicts optionallyilluminating the one or more injection sites in the injection-treatmentpattern sequentially on the surface of the body region of theindividual. In one embodiment, sequentially illuminating the one or moreinjection sites is accomplished using a single controllablelight-emitting element that alters the beam of emitted light so as toalter the location of illumination on the surface of the body region. Inone embodiment, a sequence of illuminated injection sites is generatedby sequentially activating a series of controllable light-emittingelements that sequentially illuminate different locations on the surfaceof the body region. In one embodiment, a sequence of illuminatedinjection sites is generated by projecting onto the surface of the bodyregion a sequentially changing image, e.g., a series of images in whichdigitally registered injection sites associated with the imagessequentially appear and disappear according to an injection-treatmentplan. Block 1510 of FIG. 15 further includes optional block 1520. Block1520 illustrates optionally illuminating the one or more injection sitesin the injection-treatment pattern sequentially on the surface of thebody region of the individual contingent on completing one or moreinjections at one or more previously illuminated injection sites. In oneembodiment, completion of one or more injections at a specificilluminated injection site is monitored with an image capture device.The injector itself may include a sensor, e.g., a photo-sensor, whichactivates when the injector is in the vicinity of the beam of lightilluminating an injection site. Once the system determines that aninjection has occurred at a given illuminated injection site, the nextinjection site in the sequence is illuminated and available forinjection.

FIG. 15 further includes block 1530. Block 1530 depicts optionallyilluminating at least one injection site on the surface of the bodyregion of the individual with two or more controllable light-emittingelements placed at two or more locations relative to the individual. Itis contemplated that during the course of injecting an injectable agentat an illuminated injection site, the user, e.g., a physician, otherpractitioner, or the individual may disrupt the beam of lightilluminating an injection site. In one embodiment, it may be preferableto illuminate one or more injection sites from more than one locationsrelative to the individual such that if the user performing theinjections blocks illumination from one source, e.g., by getting one'shead or hand in the way of the light emitted from one of the one or morecontrollable light-emitting elements, the illuminated injection sitewill still be visible on the surface of the body region from a second,unblocked source. As such, a redundancy in illumination is contemplatedin which multiple beams of light from multiple locations illuminate aninjection site with at least one of the beams of light illuminating agiven injection site at any point during the injection-treatment sessiondespite movement by the physician or other user that might disrupt anyone of the multiple beams of light. An example of an embodiment of asystem for illuminating an injection site on the surface of the bodyregion of an individual with two or more controllable light-emittingelements is illustrated in FIG. 5.

FIG. 16 shows further aspects of the method of FIG. 12 for guidinginjection in an individual. FIG. 16 shows that in one embodiment, themethod of FIG. 12 can optionally include block 1600. Block 1600 showsoptionally projecting one or more pieces of information onto the surfaceof the body region of the individual. Block 1600 further includesoptional blocks 1610 and 1620. Block 1610 shows optionally projectingthe one or more pieces of information onto the surface of the bodyregion of the individual at or near one or more illuminated injectionsites. Block 1620 shows optionally projecting one or more additionaltreatment parameters or an injection status update onto the surface ofthe body region of the individual. In an embodiment, the one or morepieces of information, e.g., one or more additional treatmentparameters, are meant to annotate the illuminated injection sites toprovide additional information to the user performing the injections asto the type of injectable agent, the dosage, the type of injector, thedepth or angle of injection, and/or the sequence or timing of injection.In an embodiment, the one or more pieces of information are notprojected with any specific illuminated injection site, but provideinformation that might be applicable to all of the injection sites. Forexample, a general piece of information including the type of drug andthe dosage may be projected on the body region indicating to the userthat all of the illuminated injection sites are to be injected with thesame drug at the same dosage. In an embodiment, the one or more piecesof information may provide an injection status update, e.g., a runningclock, the number of injections completed and/or remaining, or otherpieces of information pertinent to an injection treatment session.

FIG. 17 shows further aspects of the method of FIG. 12 for guidinginjection in an individual. FIG. 17 illustrates that in one embodiment,block 1210 can include one or more of optional blocks 1700 and 1710.Block 1700 depicts optionally injecting the at least one injectableagent into one or more of epidermis, papillary dermis, reticular dermis,subcutis, or muscle of the underlying tissue of the body region at ornear at least one of the one or more illuminated injection sites. Forexample, the method can include injecting one or more doses of botulinumneurotoxin into the papillary dermis at one or more illuminatedinjection sites on an individual's forehead region. For example, themethod can include injecting one or more doses of fertility hormonesinto the muscle at one or more illuminated injection sites on thesurface of an individual's upper thigh. In one embodiment, the methodcan include injecting the at least one injectable agent into one or morelines, wrinkles or folds on an individual's face, e.g., as part of acosmetic treatment. Block 1710 depicts optionally injecting the at leastone injectable agent into the underlying tissue of one or more of aforehead, a glabella, a periorbital region, a preauricular region, anear, a cheek, a lip, a nasolabial fold, a labial region, a perilablialregion, a sublabial region, a labiomental crease, or a neck region ofthe individual. For example, the method can include injecting one ormore doses of collagen at one or more illuminated injection sites on thenasolabial folds of an individual's face.

FIG. 18 shows further aspects of the method of FIG. 12 for guidinginjection in an individual. FIG. 18 illustrates that in one embodiment,block 1210 can include one or more of optional blocks 1800, 1810, 1820,1830, 1840 and 1850. Block 1800 depicts optionally injecting at leastone neurotoxin. In one embodiment, the at least one neurotoxin caninclude one or more forms of the neuromuscular blocking agent botulinumtoxin. In one embodiment, botulinum toxin is used for treating wrinklesin a facial region of an individual. For example, the one or moreilluminated injection sites can be used for guiding injection botulinumtoxin into wrinkles associated with the forehead, e.g., glabellar frownlines, of an individual's face. In one embodiment, botulinum toxin isused for treating one or more of primary axillary hyperhidrosis(excessive sweating), blepharospasm (eye twitching), strabismus(cross-eyed), cervical dystonia, chronic migraine, and upper limbspasticity. Non-limiting examples of botulinum toxin for use as aninjectable agent include onabotulinumtoxinA, abotulinumtoxinA,incobotulinymtoxinA, rimabotulinumtoxinB and like agents (see, e.g.,Park et al., Clin. Ophthalmol. (2011) 5:725-732, which is incorporatedherein by reference).

Block 1810 of FIG. 18 depicts optionally injecting at least one of asubcutaneous volume enhancer or dermal filler at or near at least one ofthe one or more illuminated injection sites. Block 1810 further includesoptional blocks 1820, 1830, and 1840. Block 1820 illustrates optionallyinjecting at least one of a collagen filler into an underlying tissue ofthe body region of the individual at or near at least one of the one ormore illuminated injection sites. For example, the one or moreilluminated injections sites can be used for guiding injection of acollagen filler into the upper or lower lip of an individual to achievelip augmentation. Other non-limiting examples of injecting collagenfiller include injecting into the grooves and/or lines that formwrinkles and sagging skin of the face. In one embodiment, the at leastone collagen filler can be used to treat depressed scars, e.g., pittedacne scars. Non-limiting examples of bovine-, porcine-, or human-derivedcollagen fillers are available and are sold under their trademarkednames ARTEFILL, COSMOPLAST, COSMODERM, EVOLENCE, ZYDERM, and ZYPLAST.For example, ZYPLAST can be injected using a 30-gauge needle into themiddle and deep reticular dermis to correct deeper lines and wrinkles orfor lip augmentation. The depth of injection can vary fromsuperficial/papillary dermis for treatment of wrinkles and fine lines tomid to deep dermis for treatment of moderate to deep facial wrinkles andfolds (see, e.g., Hanke et al., J. Am. Acad. Dermatol. (2011) 64:S66-85,which is incorporated herein by reference).

Block 1830 of FIG. 18 depicts optionally injecting at least one of ahyaluronic acid filler into an underlying tissue of the body region ofthe individual at or near at least one of the one or more illuminatedinjection sites. For example, the one or more illuminated injectionssites can be used for guiding injection of at least one hyaluronic acidfiller into an underlying tissue of a body region to temporarily smoothwrinkles, augment lips, reduce facial folds, and attenuate scars. Avariety of hyaluronic fillers are available and are sold under theirtrademarked names, including BELOTERO BALANCE (Merz Aesthetics, SanMateo, Calif.); HYALAFORM, JUVEDERM ULTRA and JUVEDERM ULTRA PLUS(Allergan, Inc., Irvine, Calif.); PERLANE and RESTYLANE (MedicisPharmaceutical Corp., Scottsdale, Ariz.); and PREVELLE and PURAGEN(Mentor Worldwide, LLC, Santa Barbara, Calif.). Hyaluronic acid can beinjected with needles ranging in size from 27 to 30 gauge to a depthranging from the mid to deep dermis to the superficial subcutaneousspace (see, e.g., Allemann & Baumann Clinical Interventions in Aging(2008) 3:629-634; Brandt & Cazzaniga Clinical Interventions in Aging(2008) 3:153-159, which are incorporated herein by reference).

Block 1840 of FIG. 18 depicts optionally injecting at least one ofadipose, fibroblasts, calcium microspheres, or poly L lactic acid intoan underlying tissue of the body region of the individual at or near atleast one of the one or more illuminated injection sites. In oneembodiment, adipose tissue can be isolated from one region of theindividual's body, e.g., the abdomen or thigh, and reinjected intoanother region of the individual's body, e.g., the face, to augment orrepair features of the facial region (see, e.g., Meier et al., Arch.Facial Plast. Surg. (2009) 11:24-28, which is incorporated herein byreference). In one embodiment, fibroblasts can be isolated from theindividual, expanded in vitro, and reinjected into the individual (see,e.g., U.S. Pat. No. 7,846,465, which is incorporated herein byreference). In one embodiment, calcium hydroxyapatite microspheres, soldunder the trademark RADIESSE (Merz Aesthetics, San Mateo, Calif.), canbe injected using a 27 gauge needle, e.g., to correct moderate to severenasolabial folds. The calcium hydroxyapatite microspheres can beinjected with an aqueous gel, the latter of which is highly viscous,requiring a larger bore needle, e.g., a 27 gauge needle. The geldegrades over the course of several months, leaving behind the calciummicrospheres to stimulate collagen synthesis. In one embodiment, poly Llactic acid (PLLA, sold under the trademark SCULPTRA by Sanofi-AventisU.S. LLC, Bridgewater, N.J.) can be injected at or below the level ofthe dermal-subcutaneous junction for augmentation of the lowertwo-thirds of the face in individuals with lipoatrophy associated withHIV infection. PLLA can also be used for cosmetic purposes as a deepdermal filler (see, e.g., Sherman Clin. Dermatol. (2009) 27:S23-S32,which is incorporated herein by reference). PLLA is viscous solution andas such requires injection using larger bore needles, e.g., 25- or26-gauge needles. In one embodiment, PLLA may be used in conjunctionwith lidocaine and/or epinephrine to lessen the pain of injection with arelatively large needle. For example, lidocaine and/or epinephrine canbe included in the injection along with the PLLA.

Block 1850 of FIG. 18 depicts optionally injecting at least one ofinsulin, an antibiotic, a hormone, a chemotherapeutic agent, cells, ananti-inflammatory agent or a biological agent into an underlying tissueof the body region of the individual at or near at least one of the oneor more illuminated injection sites. In one embodiment, injecting atleast one of insulin includes injecting at least one of rapid actinginsulin, short-acting insulins, intermediate-acting insulins, premixedinsulins, or long-acting insulins. Commercial sources of insulin areavailable from, e.g., Eli Lilly (Indianapolis, Ind.), Sanofi-AventisU.S. LLC (Bridgewater N.J.), Novo Nordisk Inc. (Princeton, N.J.), orPfizer (New York, N.Y.).

In one embodiment, injecting at least one antibiotic includes injectingat least one of penicillins, e.g., penicillin, ampicillin, piperacillin;cephalosporins and other beta-lactam drugs, e.g., cefazolin, ertapenem;tetracyclines, e.g., doxycycline; macrolides, e.g., erythromycin;clindamycin; aminoglycosides, e.g., streptomycin, gentamicin;spectinomycin; sulfonamides; quinolones and fluoroquinolones.

In one embodiment, injecting at least one hormone includes injecting atleast one of a hypothalamic or pituitary hormone, synthetic analogs,and/or antagonist thereof, e.g., adrenocorticotropic hormone,corticotropin-releasing hormone, follicle stimulating hormone,gonadotropin-releasing hormone and synthetic analogs, luteinizinghormone, prolactin; at least one of an adrenocoricosteroid, syntheticanalogs, and/or antagonists thereof, e.g., dexamethasone,hydrocortisone, prednisolone, methylprednisolone, triamicinolone;gonadal hormones, e.g., estrogens, progestins, androgens, and anabolicsteroids; glucagon and analogs thereof.

In one embodiment, injecting at least one cancer chemotherapeutic orassociated therapy includes injecting at least one of alpha interferon,erythropoietin and derivatives thereof, colony stimulating factor andanalogs thereof, somatostatin and analogs thereof.

In one embodiment, injecting at least one biological agent includesinjecting at least one of teriparatide, etanercept, interferon,abatacept, anakinra, bevacizumab, cetuximab, cyclophosphamide,gemtuzumab, muromonab-CD3, omalizumab, pegademase, immune globulin,tacrolimus, or tositumomab.

In one embodiment, injecting at least one of cells includes injectingstem cells, differentiated cells, adipose, fibroblasts, myocytes,inflammatory cells, neural cells, or any other cell type that can beinjected into an individual for use in treating a condition.

In one embodiment, injecting at least one anti-inflammatory agentincludes injection of one or more steroidal compound, e.g., one or morecorticosteroids. In one embodiment, injecting at least oneanti-inflammatory agent includes injecting at least one non-steroidalanti-inflammatory agent, non-limiting examples of which include aspirin,COX-2 inhibitor, indomethacin, diclofenac, naproxen, and ibuprofen.

In one embodiment, the at least one injectable agent is injected intothe muscle of the underlying tissue of the body region of theindividual. Non-limiting examples of injectable agents that are injectedintramuscularly include neurotoxins, codeine, morphine, methotrexate,metoclopramide, olanzapine, streptomycin, diazepam, prednisone,penicillin, interferon beta-1a, testosterone, estradiol, dimercaprol,ketamine, Lupron, maloxone, quinine, vitamin B12, Gardasil, hepatitis Avaccine, rabies vaccine, and influenza vaccine. In one embodiment, theat least one injectable agent is injected subcutaneously. Non-limitingexamples of injectable agents that are injected subcutaneously includeinsulin, morphine, diacetylmorphine, and goserelin. In one embodiment,the at least one injectable agent is injected intradermally.Non-limiting examples of injectable agents that are injectedintradermally include influenza vaccines, tuberculosis skin tests, andallergy shots.

In one embodiment, the at least one injectable agent is injected incombination with one or more analgesic agents, for example lidocaine, tolessen the pain associated with injection. For example, ZYDERM (from,e.g., McGhan Medical Corporation, Fremont, Calif.) is a collagen fillerthat includes the analgesic lidocaine.

In one embodiment, the method further includes applying one or moretopical agents to the surface of the body region of the individual priorto, during, and/or after injection treatment. The one or more topicalagents can include one or more analgesics, disinfectants, antiseptics,sterilants, therapeutic agents, or combinations thereof. Non-limitingexamples of analgesics include lidocaine, prilocaine, tetracaine,cocaine, pramoxine, dibucaine, benzocaine, dyclonine, a NSAID, or anopiate. For example, lidocaine, either alone or in combination withprilocaine as a eutectic mixture (2.5% lidocaine/2.5% prilocaine) can beused to ease the acute pain of needle insertion (see, e.g., McCleane,Curr. Opin. Anesthesiol., (2010) 23:704-707; Kundu & Achar, Am. Fam.Physician (2002) 66:99-102, which are incorporated herein by reference).In one embodiment, the at least one analgesic can include one or more ofa vapocoolant or skin refrigerant, e.g., menthol; ethyl chloride;dichlorodifluromethane mixed with trichloromonofluoromethane; orpentafluoropropane mixed with tetrafluoroethane; and the like.Non-limiting examples of disinfectants, antiseptics and/or sterilantsinclude isopropanol, silver compounds, ethanol, povidone, iodine,glutaraldehyde, formaldehyde, chlorhexidine gluconate, sodiumhypochlorite, quaternary ammoniums compounds, hydrogen peroxide, andphenols. Non-limiting examples of therapeutic agents for topical useinclude retinoids, corticosteroids, and chemotherapeutics.

In one embodiment, the one or more topical agents include one or moreantimicrobial agents. The one or more antimicrobial agents can furtherinclude at least one of an antibacterial agent, antiviral agent, orantifungal agent. In one embodiment, the at least one antimicrobial isconfigured to prevent or minimize infection associated with theinjection treatment. In one embodiment, the at least one antimicrobialagent is configured to treat or prevent or minimize other infections onthe individual's skin. Non-limiting examples of antibacterial agentscommonly used for topical applications include benzoyl peroxide, sodiumsulfacetamide, erythromycin, mupirocin, retapamulin, bacitracin,neomycin, polymyxin b/e, silver sulfadiazine, or tetracycline.Non-limiting examples of antiviral agents commonly used for topicalapplications include acyclovir, docosanol, famciclovir, imiquimod,penciclovir, valacyclovir, and vidarabine. Non-limiting examples ofantifungal agents commonly used for topical applications includeamphotericin B, butaconazole, butenafine, ciclopirox olamine,clotrimazole, econazole, ketoconazole, miconazole, naftifine, natamycin,nystatin, oxiconazole, sulconazole, terbinafine, terconazole,tioconazole, tolnaftate, and metronidazole.

In one embodiment, the surface temperature of the body region of theindividual may be altered above or below about 98.6° F. (or above orbelow about 37° C.) prior to, during, and/or after one or moreinjections. In one embodiment, the surface of the body region is cooledbelow about 98.6° F. (37° C.) prior, during and/or after injection withan injectable agent. Cooling the body region may lessen the painassociated with needle injection and/or prevent swelling and/or bruisingpost injection. In one embodiment, the surface of the body region iscooled by placing a cooling element, e.g., an ice pack, a chemical icepack, or a chilled object with a high heat capacity, onto the bodyregion of an individual. The cooling temperature can range from about10° C. to about 0° C. It is understood that the cooling temperature canfall outside this range, but is contemplated to be sufficiently coolenough to reduce pain and swelling but not so cold as to be painful tothe underlying tissue of the body region.

In one embodiment, the surface of the body region is heated above about98.6° F. (37° C.) prior, during and/or after injection with aninjectable agent. Heating the body region may increase vasodilationand/or circulation in the underlying tissue. In one embodiment, thesurface of the body region is heated by placing a heating element, e.g.,a chemical heating pack, or a heated object with a high heat capacity,onto a body region of an individual. In one embodiment, the surface ofthe body region is heated using the one or more controllablelight-emitting elements. The heating temperature can range from about40° C. to about 45° C. It is understood that the heating temperature canfall outside this range, but is contemplated to be sufficiently warmenough to increase circulation but not so warm as to be painful,damaging, or destructive to the skin, eyes, or underlying tissue of abody region.

FIG. 19 illustrates further aspects of the method of FIG. 12 for guidinginjection in an individual. FIG. 19 includes block 1900. Block 1900depicts optionally documenting an injection with the at least oneinjectable agent into the underlying tissue of the body region at ornear the at least one or more illuminated injection sites. Documentingthe injection can include documenting where the injection was made onthe body region, the type of injectable agent used for the injection,the dosage of injectable agent used at each injection site, the sequenceof injecting the injectable agent at more than one site, the timing ofinjecting the injectable agent, the angle of injection and the depth ofinjection. Documenting can further include documenting how theindividual responded to the injection, e.g., any side effects such asredness, swelling, treatment outcome and/or overcorrection of a cosmeticcondition.

Block 1900 further includes optional blocks 1910 and 1920. Block 1910shows optionally documenting the injection with at least one imagecapture device. Documenting the injection with the at least one imagecapture device can include documenting the condition of the body regionbefore and after injection, any visible adverse reactions to theinjection, e.g., swelling and/or redness, the actual act of injecting atan illuminated injection site, injection misses, injection errors,treatment outcome, and the like. Block 1920 shows optionally documentingthe injection in an electronic medical record of the individual.Documenting the injection in an electronic medical record can includedictating into the electronic medical record, typing into an electronicmedical record, and/or transmitting one or more images or videodocumenting the injection from an image capture device to theindividual's electronic medical record. In one embodiment, documentingthe injection may include a sensor on the injector that interacts withthe illuminated injection sites and wirelessly transmits informationregarding the injection process to the electronic medical record.

FIG. 20 illustrates further aspects of the method of FIG. 12 for guidinginjection in an individual. FIG. 20 includes block 2000. Block 2000shows optionally receiving at least one digital representation of thebody region of the individual, the at least one digital representationof the body region including one or more digitally registered injectionsites corresponding to the one or more illuminated injection sites. Thedigital representation can be received through a wired or wirelesstransmission from a computing device. In one embodiment, the digitalrepresentation is received directly from one or more image capturedevice.

FIG. 20 further includes block 2010. Block 2010 shows optionallyreceiving one or more images of a visual field including the bodyregion, the visual field including the one or more illuminated injectionsites on the surface of the body region and an injector in proximity toat least one of the one or more illuminated injection sites, andalerting a user if the injector is not aligned with an appropriateilluminated injection site.

In one embodiment, a method for guiding injection in an individualfurther includes verifying whether an injection-treatment plan includingone or more illuminated injection sites is appropriate for a givenindividual based on one or more patient identifiers. In one embodiment,this may include using a form of facial recognition software incombination with the one or more physical registration landmarks, e.g.,a unique pattern of freckles or other pigmented areas. As such, theability to align digital registration landmarks associated with adigital representation of a body region with a unique pattern ofphysical registration landmarks on the body region of an individual canbe used to determine whether the digital representation is being usedwith the appropriate individual.

FIG. 20 further includes block 2020. Block 2020 illustrates optionallyusing the one or more illuminated injection sites with the at least oneinjectable agent to treat one or more conditions including one or moreof a cosmetic disorder, a cosmetic need, a pain disorder, a blood vesseldisorder, a microbial infection, an inflammatory disorder, an endocrinedisorder, a neurological disorder, a muscular disorder, a skin disorder,a fertility disorder, cancer, or a vitamin deficiency.

Systems and methods are described herein for generating an injectionguide including one or more illuminated injection sites.

FIG. 21 illustrates a method implemented on a computing device forgenerating an injection guide. Block 2100 shows receiving one or moredigital images of a body region of an individual, the body regionincluding one or more physical registration landmarks. Block 2110 showsgenerating at least one digital representation of the body region usingthe one or more digital images, the at least one digital representationincluding one or more digital registration landmarks corresponding tothe one or more physical registration landmarks on the body region.Block 2120 shows adding one or more digitally registered injection sitesto the at least one digital representation of the body region in aninjection-treatment pattern, the one or more digitally registeredinjection sites registered relative to the one or more digitalregistration landmarks. Block 2130 shows generating one or more outputsignals having information for controlling one or more controllablelight-emitting elements to illuminate a location on a surface of thebody region of the individual corresponding in location to at least oneof the one or more digitally registered injection sites.

In one embodiment, the method includes receiving one or more digitalimages of a face, neck, head, torso, abdomen, upper extremity, lowerextremity, or buttocks region of an individual. In general the methodcan include receiving one or more digital images of any portion of thebody accessible to injection with an injector. As defined herein,receiving digital images includes receiving any digital informationrelated to the body region of the individual and the underlying tissue.In one embodiment, receiving one or more digital images of the bodyregion of an individual includes receiving one or more images of thesurface topography of the body region. The topography of the body regioncan include both the micro-topography, e.g., the texture and/or patternof the skin surface, and the macro-topography, e.g., anatomical featuressuch as nose, lips, cheeks, large wrinkle, joints, and the like.

The method further includes receiving one or more digital images of abody region including one or more physical registration landmarks. Inone embodiment, the one or more physical registration landmarks compriseone or more markings placed on the surface of the body region of theindividual prior to acquiring the one or more digital images. Forexample, one or more markings, e.g., a removable ink or adhesive pieces,may be placed on the surface of the body region of an individual priorto acquiring one or more digital images of the body region with an imagecapture device, e.g., a camera. In one embodiment, the one or morephysical registration landmarks comprises one or more of pigmentation,pigmented areas, tattoos, scars, blemishes, anatomical features, orsubsurface blood vessels associated with the body region of theindividual.

In one embodiment, receiving the one or more digital images of the bodyregion of an individual can include receiving one or more digital imagesof features of the body region that are themselves the focus oftreatment, for example a scar (e.g., an acne scar) or other blemish onthe surface of the skin. For example, one or more digital images of ascar on the body region can aide in determining where the one or moredigitally registered injection sites should be added to the digitalrepresentation of the body region for injection treatment of the scar.As an example, injectable dermal fillers can be used to raisedepressions in the surface of the skin caused by severe acne scarring.

In one embodiment, receiving the one or more digital images of the bodyregion can include receiving one or more digital images of body regionfeatures contraindicated as sites of injection. For example, injecting aneurotoxin, e.g., botulinum toxin, or other injectable agents directlyinto a blood vessel may lead to unwanted systemic complications. Assuch, an injection-treatment plan that includes botulinum toxininjection, for example, would necessarily avoid overlaying the one ormore digitally registered injection sites representative of illuminatedinjections sites over one or more blood vessels associated with the bodyregion. In an embodiment, one or more of the superficial blood vesselson the body region can be imaged and incorporated into the at least onedigital representation of the body region. Non-limiting examples ofnon-invasive imaging techniques for superficial blood vessels includephotoacoustic imaging, ultrasound, near-infrared imaging (see, e.g.,Wieringa et al., Ann Biomed Eng (2006) 34:1870-1878, which isincorporated herein by reference). Images of superficial blood vesselsgenerated using one or more of these methods can be combined with theimages of the body region of the individual to aid in determining aninjection-treatment plan and placement of the one or more digitallyregistered injection sites.

The one or more physical registration landmarks are represented bydigital registration landmarks in the digital representation of the bodyregion and are used to register the digitally registered injection sitesrepresentative of illuminated injection sites to a physical area on thebody region.

FIG. 22 illustrates further aspects of the method of FIG. 21 forgenerating an injection guide. Block 2100 optionally includes blocks2200, 2210, 2220, and 2230. Block 2200 shows optionally receiving theone or more digital images of the body region from a data storagedevice. For example, the one or more digital images may be received froma data storage device incorporated in a computing device. In oneembodiment, the one or more digital images are received from a datastorage device in a remote computing device. In one embodiment, the oneor more digital images can be received from a flash drive or otherportable data storage device. In one embodiment, the one or more digitalimages are received from a data storage device incorporated into animage capture device.

Block 2210 shows optionally receiving the one or more digital images ofthe body region from one or more of a camera, active scanner, or passivescanner. The one or more digital images of the body region can bereceived from one or more cameras, active scanners, or passive scannerspositioned at one or more locations relative to the individual. Forexample, multiple images received from multiple directions will allowfor obtaining information from all sides of the individual. In oneembodiment, the one or more digital images are received with sufficientdigital information to differentiate between the color of the skin andother skin features, e.g., freckles, tattoo, moles, or blemishes, thelatter of which can be used as physical registration landmarks.

In one embodiment, the one or more digital images are received from atleast one active scanner. An active scanner emits some form of radiationor light which when beamed on an individual creates a measureablereflection. The emitted radiation or light can include electromagneticradiation, ultrasound, or x-ray. Non-limiting examples of activenon-contact scanners include hand-held laser scanners as well as anumber of three-dimensional scanners (3D scanners) includingtime-of-flight scanners, triangulation laser scanners, structured-lightscanners, and modulated light scanners (see, e.g., Kolb et al., ComputerGraphics Forum (2010) 29:141-159, which is incorporated herein byreference). In one embodiment, the one or more active scanners caninclude one or more triangulation scanners in which a laser emitter, alaser dot on the surface being scanned, and a detection camera are usedto triangulate the distance between the laser and the laser dot. Thetopography of the body region, e.g., the face, differentially reflectsthe distorted light of the laser, which is then captured by acharge-coupled device (CCD) associated with the camera and convertedinto distance information using triangulation. In one embodiment, theone or more active scanners can include one or more time-of-flight laserscanners in which a laser rangefinder is used to determine the distancebetween a surface, e.g., the body region of an individual, and the laseremitter by timing the round-trip time of a pulse of light. Thetime-of-flight laser scanner scans the entire field of view one point ata time by changing the rangefinders view. In one embodiment, the one ormore active scanners can include one or more structured-light 3Dscanners in which a pattern of light is projected onto the body regionof an individual and the deformation of the projected pattern. Scannersfor scanning head, face and/or whole body are commercially available(from, e.g., Cyberware, Monterery Calif.; Accurex Measurement Inc.,Swathmore, Pa.; 3dMD Atlanta, Ga.; Konica/Minolta, Ramsey, N.J.)

In one embodiment, the one or more digital images are received from atleast one passive scanner. A passive scanner relies on detectingreflected ambient radiation, e.g., visible or infrared light. Anon-limiting example of a passive scanner includes a digital camera. Inone embodiment, the one or more passive scanners include stereoscopicsystems using two video cameras, slightly apart, imaging the sameportion of the body region of the individual. In one embodiment, thepassive scanner can include a single camera taking multiple images underdifferent lighting conditions or from different positions. As anexample, one or more digital images of the body region of an individualcan be acquired in a point-cloud format using a three-dimensionalsensing system consisting of two or more digital cameras and one or moreprojectors connected to a personal computer. The camera position andshutter can be adjusted to the body region, which is exposed tostructured light, allowing for optical representation of the surface bya cloud of up to 300,000 points in three-dimensional coordinates (see,e.g., Feng et al., Br. J. Oral Maxillofac. Surg. (2010) 48:105-109,which is incorporated herein by reference).

In one embodiment, the combination of stereophotogrammetry and 3D laserscanner techniques can be combined to generate a three-dimensional modelof the body region of an individual (see, e.g., Majid, et al.International Archives of the Photogrammetry, Remote Sensing and SpatialInformation Science. Vol. XXXVII. Part B5. (2008) 805-811; Markiewicz &Bell, Facial Plast. Surg. Clin. N. Am. (2011) 19:655-682; van Heerbeeket al., Rhinology (2009) 47:121-125, which are incorporated herein byreference).

Returning to FIG. 22, block 2220 depicts optionally receiving the one ormore digital images of the body region from one or more of an ultrasounddevice, a photoacoustic device, a thermal imaging device, a contactscanning device, a non-contact scanning device, a magnetic resonanceimage device, a computed tomography device, a capacitance measuringdevice, electromyographic device, or other biomedical imaging device.For example, skin topographic structures, e.g., wrinkles, can be imagedusing a capacitive device with sensor plates pressed lightly on the skinsurface (see, e.g., Bevilacqua et al., (2006) IEEE InternationalConference on Video and Signal Based Surveillance, pp. 53, which isincorporated herein by reference). For example, electromyography can beused to determine muscle anatomical features and in particular facialmuscle anatomical features (see, e.g., Lapatki et al., J. Neurophysiol.(2006) 95:342-354, which is incorporated herein by reference).

Block 2230 of FIG. 22 shows optionally receiving the one or more digitalimages of the body region through one or more wireless transmissions. Insome embodiments, the one or more digital images of the body region arereceived through one or more wired transmissions. In one embodiment, theone or more digital images are received through one or more of a wiredtransmission or a wireless transmission from a second computing device.For example, the one or more digital images may be captured with one ormore image capture devices at a remote location, downloaded to a secondcomputing device, the one or more digital images received from thesecond computing device through a wired or wireless transmission. In oneembodiment, the one or more digital images are received through one ormore wired or wireless transmissions directly from one or more imagecapture devices. For example, the one or more digital images may bereceived from one or more image capture devices in real-time as theimages are being acquired. Wired transmission can include, but is notlimited to, transmission through one or more telephone line, cable line,internet line, fiber optics, coaxial cables, UPT/STP or any otherlike-wired communication line. Wireless transmission can include, but isnot limited to, one or more radio or microwave transmission (e.g.,wireless LAN, Wi-Fi, wireless PAN, Bluetooth, wireless WAN, 2G/3G,broadband, MAN, WiMAX, radar and satellite communications), or infraredtransmission (e.g., point-to-point or broadcast communication).

FIG. 23 illustrates further aspects of the method of FIG. 21 forgenerating an injection guide including generating at least one digitalrepresentation of the body region. In one embodiment, the at least onedigital representation of the body region can be a series of numbers orcoordinates representative of the body region. In one embodiment, the atleast one digital representation of the body region may be visible on adisplay, e.g., a computer monitor, as a literal image of the bodyregion, e.g., a digital photograph displayed on a computer monitor orother digital display. Further aspects of generating at least onedigital representation of the body region are illustrated in blocks 2300and 2310. Block 2300 shows optionally generating the at least onedigital representation of the body region by overlaying the one or moredigital images of the body region. For example, one or more digitalimages may be received from two or more cameras positioned in asemi-circle in front of the body region being imaged. Block 2310 showsoptionally generating a three-dimensional digital model of the bodyregion using the one or more digital images and at least onethree-dimensional modeling algorithm. Generating a three-dimensionaldigital model of the body region using the received one or more digitalimages includes using a computing device and appropriate software orinstructions. In one embodiment, the one or more digital images arereceived into a computing device that is capable of aligning orregistering the images into a common coordinate system and thenintegrating the images into a single three-dimensional digital model.

In one embodiment, active or passive scanners may produce point cloudsof data that are reconstructed using one or more three-dimensionalmodeling algorithms to form a three-dimensional digital model of thebody region. For example, surface scanning software can be used toimport individual points of the body region, e.g., of the face, and thencombine them in the X, Y, and Z axes to render a three-dimensionalrepresentation of the body region. One or more modeling programs can beused for this purpose. Non-limiting examples of types of modelingprograms include polygonal mesh three-dimensional modeling programs,non-uniform rational basis spline (NURBS) surface modeling programs, oreditable feature-based computer aided design (CAD) modeling programs. Inone embodiment, the data may be modeled using a first modeling approach,for example, a NURBS based modeling program and further refined using asecond modeling approach, for example, a CAD-based modeling program.Numerous software programs are available for generatingthree-dimensional models from scanned images. For example, non-limitingexamples of CAD/CAM software programs applicable to medical imaginginclude Amira (Visage Imaging GmbH, Berlin Germany); Analyze(AnalyzeDirect, Inc, Overland Park, Kans.); iNtellect Cranial NavigationSystem (Stryker, Freiburg, Germany); iPlan (BrainLab, Westchester,Ill.); Maxilim (Medicim, Bruges Belgium), Mimics, SurgiCase CMF, andSimPlant OMS (Materialise, Leuven, Belgium); Voxim (IVS Solutions,Chemnitz, Germany), 3dMD (Atlanta, Ga.); Alma3D (Alma IT Systems,Barcelona, Spain); and ImageJ (National Institutes of Health, Boston,Mass.) (see, e.g., Markiewicz & Bell, Facial Plast. Surg. Clin. N. Am.(2011) 19:655-682, which is incorporated herein by reference). Facialfeature extraction can be acquired using one or more of an active shapemodel algorithm (see, e.g., Sun & Xie, 11^(th) IEEE InternationalConference on Communication Technology Proceedings, (2008) pp. 661-664;Zheng & Yang IEEE Proceedings of the Seventh International conference onMachine Learning and Cybernetics, (2008) pp. 2841-2845, which areincorporated herein by reference). Other software packages capable ofgenerating a three-dimensional digital model from one or more digitalimages of a body region of an individual can be used for this purpose.Additional approaches for generating three-dimensional digital modelsare described in Bernardini & Rushmeier Computer Graphics Forum (2002)21:149-172, which is incorporated herein by reference.

FIG. 23 illustrates an embodiment of the method FIG. 21 for generatingan injection guide that optionally includes block 2320. Block 2320 showsoptionally generating an injection-treatment plan based on analysis ofthe at least one digital representation of the body region. Theinjection-treatment plan, as illustrated in block 2360, can include atleast one of one or more injection sites, a pattern of injection sites,a type of injectable agent, a type of injector, a dosage of aninjectable agent, an injection sequence, an injection timing, aninjection depth, and/or an injection angle. In one embodiment, asillustrated in block 2330, generating an injection-treatment plan basedon analysis of the at least one digital representation of the bodyregion can include identifying an area of the body region in need oftreatment by comparison of the at least one digital representation ofthe body region with at least one stored representation of at least onecomparable body region. In one embodiment, as shown in block 2340 ofFIG. 23, the injection-treatment plan comprises one or more injectionsof at least one injectable agent arranged in an injection-treatmentpattern specific for the individual. In some embodiment, as shown inblock 2350 of FIG. 23, the injection-treatment plan comprises one ormore injections of at least one injectable agent arranged in aninjection-treatment pattern specific for a condition being treated.

In one embodiment, generating an injection-treatment plan can includegenerating an injection-treatment plan based on one or more digitalimages of the body region of an individual in at least one firstexpression state and at least one second expression state. For example,one or more images of a body region of an individual's face can beacquired while the individual is in a first expression state, e.g., in arelaxed state, and used to reveal lines or wrinkles present on theindividual's face in the first expression state. One or more images ofthe individual's face are acquired in a second expression state, e.g., atensed or animated state. Non-limiting examples of tensed or animatedstates include laughing, smiling, frowning, grimacing or othernon-relaxed states of the individual's face. The one or more images ofthe individual's face in the second expression state, e.g., the animatedstate, can be used to reveal additional lines or wrinkles present on theindividual's face in the second expression state relative to the firstexpression state, e.g., the relaxed state. For example, the one or moreimages of the individual's face can be acquired while the individual isfrowning and generating associated frown-line/wrinkles (glabellar lines)between the eyebrows. As another example, the one or more images of thebody region of the individual's face can be acquired while theindividual is smiling and generating laugh lines (nasolabial folds)and/or crow's feet near the eyes. In one embodiment, comparing the oneor more digital images of the body region of the individual in the atleast one first expression state and the at least one second expressionstate to generate an injection-treatment plan includes overlaying theone or more digital images in the first expression state and the one ormore digital images in the second expression state to identify one ormore areas of the body region in need of treatment. For example, the oneor more images of the individual's face in a first expression state,e.g., a relaxed state, are overlaid with the one or more images of theindividual's face in a second expression state, e.g., an animated state.In this manner, areas in need of treatment, e.g., frown lines betweenthe eye brows or smile lines around the mouth, can be identified andplaced into the at least one digital representation of the body regionand viewed by the physician or other practitioner. Theinjection-treatment plan including at least one treatment parameter canthen be formulated based on the treatment need. Accordingly, one or moredigitally registered injection sites indicative of one or moreinjections sites and/or at least one treatment parameter can be addedeither automatically by the computing device or by a physician, otherpractitioner, or the individual to the at least one digitalrepresentation of the body region.

FIG. 24 illustrates further aspects of the method of FIG. 21 forgenerating an injection guide. Block 2120 shows adding one or moredigitally registered injection sites to the at least one digitalrepresentation of the body region in an injection-treatment pattern, theone or more digitally registered injection sites registered relative tothe one or more digital registration landmarks and optionally includesblocks 2400, 2410, 2420, and 2430. Block 2400 shows optionally addingthe one or more digitally registered injection sites automatically basedon a computed injection-treatment plan. For example, the one or moredigitally registered injection sites can be automatically added in aninjection-treatment pattern based on computational analysis of the atleast one digital representation of the body region of the individual.The computational analysis includes determining where treatment isneeded on the body region and the appropriate pattern of injection sitesto administer that treatment. In one embodiment, the pattern ofinjection sites is generic for a particular condition or treatmentoption. In one embodiment, the pattern of injection sites is specific toan individual, patterned to accommodate specific needs and/or anatomicalfeatures of the individual. In one embodiment, the pattern of injectionsites is part of an injection-treatment plan, the injection-treatmentplan is either a generic injection-treatment plan, aninjection-treatment plan specific for an individual, or combinationsthereof.

A computed injection-treatment plan can include a comparison of the atleast one digital representation of the body region with stored datathat includes one or more images of standard, normal or ideal bodyregions or previously captured images of the body region of theindividual. In one embodiment, the stored data includes idealizedaesthetics of a female or male face (see, e.g., Carruthers et al.,Plast. Reconstr. Surg. (2008) 121 (Suppl):5S-30S, which is incorporatedherein by reference). In one embodiment, the stored data includenormalized skin characteristics based on age or other demographics (see,e.g., Wolff et al., Fertil. Steril. (2011) 95:658-662, which isincorporated herein by reference). In one embodiment, the one or moredigitally registered injection sites can be added automatically to theat least one digital representation of the body region by a computingdevice based on data from the database of stored treatment parameters.In one embodiment, the computed injection-treatment plan can includealgorithms for predicting the outcome of a particular treatment regimen.For example, the computed injection-treatment plan may be used to showan individual via a display, e.g., a computer monitor, how a givenfacial feature, e.g., nasolabial folds, will change in response toinjection of an injectable agent, e.g., a dermal filler.

Block 2410 of FIG. 24 shows optionally adding the one or more digitallyregistered injection sites with a user input device. The user inputdevice can include a keyboard or interactive display panel, e.g., atouchpad or stylus. In one embodiment, the user input device is akeyboard in communication with the computing device that is implementingthe method for generating an injection guide. In one embodiment, theuser input device is a wireless device, e.g., a cell phone or otherhandheld device, capable of wirelessly adding one or more digitallyregistered injection sites to the at least one digital representation ofthe body region. In one embodiment, the one or more digitally registeredinjection sites can be added by a physician or other practitioner usingan input device based on consulting data from a database of storedtreatment parameters. In one embodiment, the one or more digitallyregistered injection sites can be added to the at least one digitalrepresentation of the body region based on preferences of theindividual. For example, the individual can sit with a physician orother practitioner in front of a display, e.g., a computer monitor, andinteractively add or subtract one or more digitally registered injectionsites. In one embodiment, the individual is also able to see theconsequences, e.g., predicted changes in facial features or other bodystructures, of adding a digitally registered injection site to a givenlocation of the digital representation of the body region.

Block 2420 of FIG. 24 shows optionally adding one or more of a dot, acrosshair, a circle, or concentric circles representative of the one ormore digitally registered injection sites to the at least one digitalrepresentation of the body region. The one or more dot, crosshair,circle, or concentric circles representative of the one or moredigitally registered injection site will be illuminated onto the surfaceof the body region of the individual to indicate one or more injectionsites on the body region. It is intended that actual injection into theunderlying skin of the body region will occur at or near one or moredot, crosshair, circle, or concentric circles illuminated on the surfaceof the body region. For example, injection may occur at thecross-section of lines comprising the crosshairs, in the middle of theconcentric circles, or in the center of the circle or dot.

Block 2430 of FIG. 24 shows optionally adding one or more of a letter,number, shape, symbol, color, or combination thereof representative ofthe one or more digitally registered injection sites to the at least onedigital representation of the body region. The one or more of a letter,number, shape, symbol, color, or combinations thereof representative ofthe one or more digitally registered injection sites will be illuminatedonto the surface of the body region of the individual to indicate one ormore injection sites on the body region. In one embodiment, the one ormore of the letter, number, shape, symbol, color, or combinationsthereof further represent at least one treatment parameter, asillustrated in block 2440. In one embodiment, the one or more letter,number, shape, symbol, color, or combinations thereof indicates both thesite of injection as well as a treatment parameter associated with thatsite of injection. For example, a blue X may be added to the digitalrepresentation, the blue color indicative of a dose of a particularneurotoxin, e.g., 5 Units of botulinum toxin, and the X indicating wherethe injection should be made. In one embodiment, two or more letters,numbers, shapes, symbols, colors, or combinations thereof areilluminated on the surface of the body region. For example, a firstletter, number, shape, symbol, or color may indicate an injection sitewhile a second letter, number, shape, or color may indicate one or moretreatment parameters. Block 2450 shows optionally wherein the one ormore of a letter, number, shape, symbol, color, or combinations thereofare representative of at least one of an injection site, a type ofinjectable agent, a type of injector, a dosage of an injectable agent, asequence of injecting an injectable agent, a timing of injection aninjectable agent, an injection depth, or an injection angle.

In one embodiment, the one or more of a letter, number, shape, symbol,color, or combination thereof are representative of at least one type ofinjectable agent to be injected at one or more illuminated injectionsite. The type of injectable agent can include one or more of aneurotoxin, subcutaneous dermal enhancer, dermal filler, insulin,antibiotic, hormone, chemotherapeutic agent, anti-inflammatory agent, orbiological agent, non-limiting examples of which have been describedabove herein. Illuminating the surface of the body region with one ormore of a letter, number, shape, symbol, color, or combination thereofindicative of other injectable agents not explicitly described herein isalso contemplated. In one embodiment, the one or more letter, number,shape, symbol, color, or combination thereof representative of the oneor more digitally registered injection sites are representative of thedosage of a particular injectable agent, e.g., the units of botulinumtoxin or milliliters of collagen filler, to be injected at a givenilluminated injection site.

In one embodiment, the one or more of a letter, number, shape, symbol,color, or combination thereof are representative of at least one type ofinjector to be used at one or more illuminated injection site. In oneembodiment, the injector includes a needle attached to a syringe, e.g.,a hypodermic needle, for penetrating the surface of the body region.Other needle systems are contemplated, including one or moremicroneedles. In one embodiment, the injector is needleless,non-limiting examples of which include jet injectors, electroporation,iontophoresis, ultrasound, micro-shock wave, powder injection, and tapestripping (see, e.g., Jagadeesh et al., Clin. Vaccine Immunol. (2011)18:539-545, which is incorporated herein by reference). In oneembodiment, the at least one type of injector is a syringe with astandard length injection needle. For example, standard injectionneedles range in length from 3/16 inches (5 mm) to 1½ inches (38 mm)from the tip of the needle bevel to the needle hub. The choice ofinjection needle will also be dependent upon how deep the injection isintended to go. For example, needles ranging in length from ½ inch to ⅝inch can be used for subcutaneous injections, while needles ranging inlength from 1 inch to 1½ inch can be used for intramuscular injections.Injection needles are further defined by the outer diameter, i.e.,gauge, of the needle shaft. The gauge of an injection needle isinversely proportional to its outer diameter. Injections needle range ingauge from 7 gauge (outer diameter approximately 4.6 mm) to 34 gauge(outer diameter approximately 0.19 mm). Injection needles commonly usedfor injecting agents into mammalian tissue range in size from 21 to 32gauge.

In one embodiment, the one or more of a letter, number, shape, symbol,color, or combination thereof are representative of at least one depthof injection at the one or more illuminated injection sites. The depthto which a needle, for example, is inserted at any given illuminatedinjection site and into the underlying tissue of the body region isdependent upon both the specific features of the body region and on theinjectable agent being injected at said illuminated injection site. Forexample, specific features of an individual's face could dictateinjection depth, including the severity of lines or wrinkles and/or thethickness of the tissue layers at any given injection site. For example,the thickness of the epidermis (top layer of skin) is about 0.05 mm nearthe eye lids while the epidermis on the rest of the face is on averageof about 0.1 to 0.3 mm. In addition, the injection depth may bedependent upon the age of the individual, as the tissue layers thin withincreasing age. Furthermore the depth may be dependent upon theinjectable agent being injected and the type of tissue into which saidinjectable agent is injected. For example, the dermal filler hyaluronicacid can be injected into the superficial papillary dermis for treatingfine wrinkles and scars, but is injected deeper into the reticulardermis for deeper lines. Similarly, collagen filler can be injected intothe papillary and middle dermis to treat fine lines and wrinkles in theupper lip, the periorbital area, and glabella of the face.Polymethylmethacrylate microspheres filler can be injected subdermally,e.g., into the border of the dermis and subcutaneous fat, to treatrhytids and scars. Botulinum toxin can be injected to about 2 to 3 mmbelow the surface of the skin.

In one embodiment, the one or more of a letter, number, shape, symbol,color, or combination thereof are representative of at least one angleof injection at the one or more illuminated injection sites. The angleat which a needle of an injector is inserted into the underlying tissueof the body region is dependent upon the nature of the injectable agentand the depth to which the injectable agent is being injected. In oneembodiment, the at least one injectable agent is injected with aninjector at the one or more illuminated injection sites at a 90 degreeangle relative to the surface of the body region. In one embodiment, theat least one injectable agent is injected with an injector at the one ormore illuminated injection sites at less than a 90 degree angle relativeto the surface of the body region. For example, injections into themuscle with, e.g., penicillin may be done with an injector at a 90degree angle; injections into the subcutaneous tissue with, e.g.,morphine, may be done with an injector at a 45 degree angle; andinjections into the epidermis or dermis with, e.g., a vaccine may bedone with an injector at a 10 to 15 degree angle.

FIG. 25 illustrates further aspects of the method of FIG. 21 forgenerating an injection guide including generating one or more outputsignals having information for controlling one or more controllablelight-emitting elements to illuminate a location on a surface of thebody region of the individual corresponding in location to at least oneof the one or more digitally registered injection sites. The one or moreoutput signals having information for controlling one or more of thecontrollable light-emitting elements can include one or more outputsignals having information for controlling one or more of an on/offfunction, position, intensity, focus, color of emitted light, or patternof emitted light. The one or more output signals having information forcontrolling one or more controllable light-emitting elements can includeone or more output signals having information for dynamicallycontrolling one or more of an on/off function, position, intensity,focus, color of emitted light, or pattern of emitted light. Dynamicallycontrolling the one or more controllable light-emitting elements caninclude controlling a spatial or temporal sequence of illumination onthe surface of the body region. For example, the method can includegenerating one or more output signals having information for controllingan on/off sequence or color of emitted light during the course of aninjection treatment such that the different injection sites areilluminated in a sequence or different colors are illuminated atdifferent times on the surface of the body region as part of aninjection-treatment plan.

Block 2130 of FIG. 25 optionally includes blocks 2500, 2510, and 2520.Block 2500 shows optionally generating one or more output signals havinginformation for controlling one or more of a controllable projector,light-emitting diode, laser, laser diode, collimated light source, orfocused light source. Non-limiting examples of controllablelight-emitting elements have been described above herein. Block 2510shows optionally generating one or more output signals havinginformation for controlling one or more controllable light-emittingelements to illuminate a location on the surface of the body region ofthe individual with one or more spots, crosshairs, circles, orconcentric circles corresponding in location to at least one of the oneor more digitally registered injection sites. Block 2520 showsoptionally generating one or more output signals having information forcontrolling one or more controllable light-emitting elements toilluminate a location on the surface of the body region of theindividual with one or more of a letter, number, shape, symbol, color,or combination thereof corresponding in location to at least one of theone or more digitally registered injection sites.

FIG. 26 illustrates further aspects of the method of FIG. 21 forgenerating an injection guide. Block 2130 optionally includes blocks2600, 2610, and 2620. Block 2600 shows optionally generating one or moreoutput signals having information for controlling the one or morecontrollable light-emitting elements to illuminate the location on thesurface of the body region of the individual corresponding in locationto the at least one of the one or more digitally registered injectionsites in accordance with an injection-treatment plan. Block 2610 showsoptionally generating one or more output signals having information forcontrolling the one or more controllable light-emitting elements tosequentially illuminate one or more locations on the surface of the bodyregion of the individual corresponding in location to one or moredigitally registered injection sites in accordance with aninjection-treatment plan. Block 2610 further includes block 2620. Block2620 shows optionally generating one or more output signals havinginformation for controlling the one or more controllable light-emittingelements to sequentially illuminate the one or more locations on thesurface of the body region of the individual based on accuratecompletion of an injection at a previously illuminated injection site.

FIG. 27 illustrates further aspects of the method of FIG. 21 forgenerating an injection guide. Block 2700 shows optionally generatingone or more output signals having information for projecting one or moreannotations on the surface of the body region of the individual at ornear one or more illuminated injection sites. The one or moreannotations can include letters, text, numbers, shapes, symbols, colors,or combinations thereof representative of one or more pieces ofinformation relating to one or more treatment parameters and/or aninjection status update. In one embodiment, the one or more annotationsare projected in proximity to the one or more illuminated injectionsites and provide specific instructions for a given injection site. Inone embodiment, the one or more annotations are projected on the bodyregion without regard for the illuminated injection sites and mayprovide general instructions for injecting at one or more illuminatedinjection sites. For example, annotations may be projected on the bodyregion to instruct the user to inject all illuminated injection siteswith a given injectable agent, e.g., a dermal filler, at a given dose,e.g., one milliliter per sub-dermal injection.

FIG. 27 further includes block 2710. Block 2710 shows optionallygenerating one or more output signals having information for adjustingthe one or more controllable light-emitting elements so as to align oneor more illuminated injection sites relative to the one or more physicalregistration landmarks on the body region of the individual tosubstantially correspond to the at least one digital representation ofthe body region.

FIG. 28 illustrates further aspects of the method of FIG. 21 forgenerating an injection guide. FIG. 28 includes block 2800. Block 2800shows optionally receiving in real-time one or more second digitalimages of the body region of the individual including the one or morephysical registration landmarks and the one or more illuminatedinjection sites on the surface of the body region; and generating one ormore output signals having information for adjusting the one or morecontrollable light-emitting elements so as to align the one or moreilluminated injection sites relative to the one or more physicalregistration landmarks on the body region to substantially correspond tothe at least one digital representation of the body region.

A system is described herein comprising a computer processor andnon-transitory signal-bearing medium bearing one or more instructionsfor generating an injection guide. FIG. 29 illustrates an embodiment ofsuch a system. System 2900 includes computer processor 2910 andnon-transitory signal-bearing medium 2920. Non-limiting examples andembodiments of a computer processor including a computing device havebeen described herein, e.g., in FIG. 2.

Non-transitory signal-bearing medium 2920 stores instructions and/ordata for use in generating the injection guide. In an embodiment,non-transitory signal-bearing medium 2920 can be computer readablemedia. In an embodiment, non-transitory signal-bearing medium 2920 canbe recordable-type media. Computer readable media may also berecordable-type media, and the qualities of being “computer readable”and “recordable-type” should not be construed as being mutuallyexclusive, though in some cases a computer readable media may not be arecordable-type media, and vice versa. Machine readable media includevolatile and nonvolatile, removable and non-removable media implementedin any method or technology for storage of information such as machinereadable instructions, data structures, program modules, or other data.Non-transitory signal-bearing media include, but are not limited to,random-access memory (RAM), read-only memory (ROM), electricallyerasable programmable read-only memory (EEPROM), flash memory, or othermemory technology, CD-ROM, digital versatile disks (DVD), or otheroptical disk storage, magnetic cassettes, magnetic tape, magnetic diskstorage, or other magnetic storage devices, or any other media which canbe used to store the desired information and which can be accessed bycomputer processor 2910. In a further embodiment, computer storage mediamay include a group of computer storage media devices. In an embodiment,machine readable media may include an information store. In anembodiment, an information store may include a quantum memory, aphotonic quantum memory, or atomic quantum memory. Combinations of anyof the above may also be included within the scope of non-transitorymachine readable media.

Non-transitory signal-bearing medium 2920 bearing one or moreinstructions for generating an injection guide further includes one ormore instructions 2930 for receiving one or more digital images of abody region of an individual including one or more physical registrationlandmarks; one or more instructions 2940 for generating at least onedigital representation of the body region using the one or more digitalimages, the at least one digital representation including one or moredigital registration landmarks corresponding to the one or more physicalregistration landmarks on the body region, one or more instructions 2950for adding one or more digitally registered injection sites to the atleast one digital representation of the body region, the one or moredigitally registered injection sites registered relative to the one ormore digital registration landmarks; and one or more instructions 2960for generating one or more output signals having information forcontrolling one or more controllable light-emitting elements toilluminate a location on a surface of the body region of the individualcorresponding in location to at least one of the one or more digitallyregistered injection sites.

The non-transitory signal-bearing medium including one or moreinstructions for receiving one or more digital images of a body regionfurther includes one or more instructions for receiving one or moredigital images of a face, head, neck, torso, abdominal, upper extremity,lower extremity, buttocks region, or any other region accessible toinjection of an injectable agent. The one or more body regions includeone or more physical registration landmarks, the physical registrationlandmarks including one or more markers placed on a surface of the bodyregion and/or one or more of a pigmentation, pigmented area, anatomicalfeature, subsurface blood vessel, blemish, scar, or tattoo, non-limitingexamples of which have been described herein.

FIG. 30 illustrates further aspects of the system of FIG. 29. In anembodiment, non-transitory signal-bearing medium 2920 including one ormore instructions 2930 for receiving one or more digital images of abody region can optionally include one or more instructions 3000 forreceiving the one or more digital images from a second computing device3010 through one or more wired 3020 or wireless 3030 transmission.

FIG. 31 illustrates further aspects of the system of FIG. 29. In anembodiment, non-transitory signal-bearing medium 2920 including one ormore instructions 2930 for receiving one or more digital images of abody region can optionally include one or more instructions 3100 forreceiving the one or more digital images from at least one image capturedevice 3110 through one or more wired 3120 or wireless 3130transmissions. In addition, image capture device 3110 is able to receiveone or more wired 3120 or wireless 3140 transmissions from computerprocessor 2910. Image capture device 3110 includes at least one of acamera, active scanner, passive scanner, ultrasound device,photoacoustic device, thermal imaging device, contact scanning device,magnetic resonance imaging device, computed tomography device,capacitance measuring device, or other biomedical imaging device,non-limiting examples of which have been described herein.Non-transitory signal-bearing medium 2920 optionally includes one ormore instructions 3150 for controlling one or more functions of the atleast one image capture device. One or more instructions 3150 optionallyinclude one or more instructions 3160 for controlling acquisition of theone or more digital images of the body region of the individual with theat least one image capture device 3110 and/or one or more instructions3170 for controlling one or more of an on/off function, positioningfunction, scanning rate function, exposure function, or energy emissionfunction of the at least one image capture device 3110. One or moreinstructions 3150 can further include one or more instructions forcontrolling the quality and/or quantity of radiation, e.g., light,projected on the individual and/or one or more instructions for causingmovement of the at least one capture image capture device to allow imagecapture from different positions or angles relative to the individual.

In one embodiment, the non-transitory signal-bearing medium includingone or more instructions 2940 for generating the at least one digitalrepresentation of the body region using the one or more digital imagesincludes one or more instructions for overlaying the one or more digitalimages of the body region of the individual to generate the at least ondigital representation of the body region. In one embodiment, thenon-transitory signal-bearing medium includes one or more instructionsfor generating a three-dimensional representation of the body regionfrom the one or more digital images. In one embodiment, the one or moreinstructions for generating the at least one digital representation ofthe body region include one or more instructions associated with analgorithm configured to generate a three-dimensional representation ofthe body region using the one or more received digital images. Examplesof algorithms and software programs for three-dimensional modeling havebeen described above herein.

FIG. 32 illustrates an embodiment of a system for generating aninjection guide. System 3200 includes a computer processor 3210 andnon-transitory signal-bearing medium 3220 bearing one or moreinstructions for generating an injection guide including one or moreinstructions 3230 for receiving one or more digital images of a bodyregion of an individual including one or more physical registrationlandmarks; one or more instructions 3240 for generating at least onedigital representation of the body region using the one or more digitalimages, the at least one digital representation including one or moredigital registration landmarks corresponding to the one or more physicalregistration landmarks on the body region; one or more instructions 3250for generating an injection-treatment plan based on analysis of the atleast one digital representation of the body region; one or moreinstructions 3260 for adding one or more digitally registered injectionsites to the at least one digital representation of the body regionbased on the injection-treatment plan, the one or more digitallyregistered injection sites registered relative to the one or moredigital registration landmarks; and one or more instructions 3270 forgenerating one or more output signals having information for controllingone or more controllable light-emitting elements to illuminate alocation on a surface of the body region of the individual correspondingin location to at least one of the one or more digitally registeredinjection sites.

The non-transitory signal-bearing medium including one or moreinstructions 3250 for generating an injection-treatment plan based onanalysis of the at least one digital representation of the body regionincludes one or more instructions 3252 for identifying an area of thebody region of the individual in need of treatment based on comparisonof the at least one digital representation of the body region of theindividual with one or more stored digital representations of acomparable body region. In one embodiment, the one or more storeddigital representations of a comparable body region include one or morehistorical digital representations of the comparable body region of theindividual. For example, the one or more historical digitalrepresentations of the body region can include one or more digitalrepresentations of the body region of the individual generated earlierin time, when the individual was younger or prior to and/or afterprevious injection treatment. For example, the historical digitalrepresentation of a body region, e.g., the face of the individual, mightinclude an enhancement with a dermal filler, fuller cheeks or lips, andcan be compared with the a current digital representation to calculatean injection-treatment plan. In one embodiment, the one or more storeddigital representations of a comparable body region include one or moreidealized digital representations of the comparable body region. Thecomparison of the at least one digital representation and the one ormore stored digital representations of a comparable body region by, forexample, an overlay and/or subtractive process is used to identify areasin need of treatment. Once an area has been identified as an area inneed of treatment, the computer processor may automatically add one ormore digitally registered injection sites to the digital representationlocation corresponding to injection site locations. In one embodiment,the one or more instructions for adding the one or more digitallyregistered injection sites are based on an outcome defined by theindividual. For example, the individual may request enhanced lips orreduced frown lines based on analysis of, e.g., viewing the at least onedigital representation on a display, e.g., a computer monitor.

The non-transitory signal-bearing medium further includes one or moreinstructions 3254 for receiving one or more inputs regarding theinjection-treatment plan from a user through a user input device. Forexample, a physician or other practitioner may enter theinjection-treatment plan including the number and type of injectionsusing a user input device, e.g., a keyboard or touchpad. In oneembodiment, the individual may choose an idealized digitalrepresentation of a comparable body region, e.g., idealized eyebrows orcheeks bones, and the physician or other practitioner instructs thecomputer processor to compare the idealized digital representation withthe at least one digital representation of a comparable body region ofthe individual to generate an injection-treatment plan. In oneembodiment, the injection-treatment plan is specific to the individual.For example, treatment with a collagen filler to augment certainportions of an individual's face might be specific to the desiredoutcome, age, and quality of the individual's skin. In one embodiment,the injection-treatment plan is specific to the condition being treated.For example, a course of antibiotics administered to an upper thigh orabdominal region might be specific for a type of bacterial infection andas such the treatment parameters, e.g., the type of injectable agent,the injection sites, and the dosage, etc., may be generic for that typeof bacterial infection.

The non-transitory signal-bearing medium further includes one or moreinstructions 3256 for generating the injection-treatment plan usinginformation stored in a data storage device. The information stored in adata storage device can include any of a number of parameters pertinentto an injection-treatment plan including, but not limited to, one ormore of a diagnosis, a condition, a type of injectable agent, a dose ofan injectable agent, an injection treatment pattern, a type of injector,a sequence of injection, a timing of injection, an injection depth, oran injection angle. For example, the information stored in the datastorage device can include treatment options, e.g., injectable agents,for a given condition as well as dosing information and informationregarding needle penetration and needle size specific for any giveninjectable agent. The information stored in a data storage device canfurther include the individual's medical record, a record of pastinjection-treatments, a record of past injection-treatment plans,adverse reactions to previous injection-treatments, skin properties,individual treatment preferences, comorbidities, age, weight, gender,and allergies, any or all of which can be taken into consideration whilegenerating the injection-treatment plan.

FIG. 33 illustrates further aspects of the system of FIG. 29.Non-transitory signal-bearing medium 2910 includes one or moreinstructions 2950 for adding one or more digitally registered injectionsites to the at least one digital representation of the body region. Inone embodiment, the non-transitory signal-bearing medium optionallyincludes one or more instructions 3300 for adding the one or moredigitally registered injection sites to the at least one digitalrepresentation of the body region in an injection-treatment-pattern aspart of an injection-treatment plan. In one embodiment, thenon-transitory signal-bearing medium includes one or more instructions3310 for automatically adding the one or more digitally registeredinjection sites to the at least one digital representation of the bodyregion. For example, the computer processor and associatednon-transitory signal-bearing medium may be operable to design aninjection-treatment plan that includes one or more injection sites in aninjection-treatment pattern and automatically add digitally registeredinjection sites representative of the proposed injection sites to adigital representation of the body region based on theinjection-treatment plan. In one embodiment, the non-transitorysignal-bearing medium includes one or more instructions 3320 for addingthe one or more digitally registered injection sites to the at least onedigital representation of the body region using a user input device. Forexample, a physician or other practitioner may use a keyboard, touchpad,or stylus associated with the computing device and either directly addthe digitally registered injection sites or enter information that wouldallow the computer processor to automatically add the digitallyregistered injection sites. For example, the user may enter coordinatesto indicate where a digitally registered injection site should be placedrelative to one or more digital registration landmarks corresponding toone or more physical registration landmarks on the body region.

Referring again to FIG. 33, in one embodiment, the non-transitorysignal-bearing medium optionally includes one or more instructions 3330for adding one or more colors, letters, numbers, shapes, symbols, orcombinations thereof representative of the one or more digitallyregistered injection sites to the at least one digital representation ofthe body region. In one embodiment, the one or more shapesrepresentative of one or more digitally registered injection sitesinclude one or more dots, crosses, rings, concentric circles, orcrosshairs representative of the one or more digitally registeredinjection sites. For example, the one or more digitally registeredinjection sites may be represented by dots of varying size, the exactsize of the dot dependent upon the accuracy required in performing aninjection at the injection site represented by the digitally registeredinjection site.

In one embodiment, the one or more colors, letters, numbers, shapes,symbols, crosshairs, or combinations thereof representative of thedigitally registered injection sites comprise information pertaining toat least one treatment parameter. The non-transitory signal-bearingmedium can include one or more instructions for adding colors, letters,numbers, shapes, symbols, crosshairs, or combinations thereof thatcomprise information pertaining to any or all aspects of aninjection-treatment plan including, but not limited to, at least one ofan injection site, a type of injectable agent, a dosage of an injectableagent, a type of injector, a dosing schedule, an injection depth, or aninjection angle, non-limiting examples of which have been describedelsewhere herein. The type of injectable agent can include, but is notlimited to, a neurotoxin, subcutaneous dermal enhancer, dermal filler,insulin, antibiotic, hormone, chemotherapeutic agent, anti-inflammatoryagent, cells, or biological agent. The injection depth can be about 0.5mm to about 25 mm below the surface of the skin. In some embodiments,the injection depth is dependent upon the type of injectable agent, theinjection site, and/or the condition being treated. The injection anglecan be about greater than 0 degrees to about less than or equal to 90degrees. In some embodiments, the injection angle is dependent upon oneor more of the type of injectable agent, the injection site, or thecondition being treated. In one embodiment, the dosing schedule includesa temporal sequence of injection an injectable agent at two or moreinjection sites. In one embodiment, the dosing schedule includes atemporal sequence of injecting two or more injectable agents at one ormore injection sites.

In one embodiment, the system further includes non-transitorysignal-bearing medium bearing one or more instructions for generating aninjection guide including one or more instructions for adding one ormore annotations to the at least one digital representation of the bodyregion. The one or more annotations include one or more pieces ofinformation pertaining to the injection treatment. In one embodiment,the annotations are only meant to be seen on a display, e.g., a monitorassociated with the computer processor. In one embodiment, the one ormore annotations are projected onto a surface of the body region of theindividual at or near one or more illuminated injection sites. The oneor more annotations can be represented by one or more letters, numbers,shapes, symbols, text, colors, or combinations thereof. In oneembodiment, the one or more annotations are representative of one ormore treatment parameters. In one embodiment, the one or moreannotations are representative of one or more injection status updates.

FIG. 34 illustrates further aspects of the system of FIG. 29.Non-transitory signal-bearing medium 2920 bearing one or moreinstructions 2960 for generating one or more output signals havinginformation for controlling one or more controllable light-emittingelements to illuminate a location on a surface of the body region of theindividual corresponding in location to at least the one or moredigitally registered injection sites can optionally include one or moreinstructions 3400 for generating one or more output signals havinginformation for controlling one or more of an on/off function, focus,intensity, position, color of light emitted, pattern of light emitted,sequencing, or timing of the one or more controllable light-emittingelements. The one or more output signals are generated based on thedigital representation of the body region, the one or more digitallyregistered injection sites, and the injection-treatment plan, any or allof which dictate when, where, and how light from the one or morecontrollable light-emitting elements should be illuminated on thesurface of the body region. One or more instructions 2960 for generatingone or more output signals having information for controlling one ormore controllable light-emitting elements can optionally include one ormore instructions 3410 for generating one or more output signals havinginformation for controlling one or more controllable light-emittingelements to illuminate one or more locations on the surface of the bodyregion of the individual in a temporal sequence in accordance with aninjection-treatment plan, the one or more locations corresponding to theone or more digitally registered injection sites. For example, the oneor more output signal can have information for sequentially turning onand off specific controllable light-emitting elements in an array ofcontrollable light-emitting elements. For example, the one or moreoutput signal can have information for moving one or more controllablelight-emitting element over time so as to sequentially illuminatedifferent locations on the surface of the body region.

In one embodiment, non-transitory signal-bearing medium 2920 bearing oneor more instructions for generating an injection guide can furtherinclude one or more instructions 3420 for generating one or more outputsignals having information for controlling one or more controllablelight-emitting elements to project one or more annotations onto thesurface of the body region of the individual. One or more instructions3420 can further include one or more instructions for generating one ormore output signals having information for controlling the one or morecontrollable light-emitting elements to project the one or moreannotations at or near one or more illuminated injection sites on thesurface of the body region of the individual. In one embodiment, theinjection sites are illuminated with a first set of controllablelight-emitting elements, e.g., one or more laser diodes, and the one ormore annotations are projected with a second set of controllablelight-emitting elements, e.g., a projector. In one embodiment, a singlecontrollable light-emitting element, e.g., a projector, illuminates theone or more injection sites as well as projects the one or moreannotations.

FIG. 35 illustrates aspects of a system 3500 including computerprocessor 3510 and non-transitory signal-bearing medium 3520 bearing oneor more instructions for generating an injection guide. System 3500further includes an image capture device 3530 which is operably linkedto computer processor 3510 by either wired 3540 or wireless 3550 means.Non-transitory signal-bearing medium 3520 includes one or moreinstructions 3570 for receiving one or more digital images of a bodyregion of an individual including one or more physical registrationlandmarks; one or more instructions 3575 for generating at least onedigital representation of the body region using the one or more digitalimages, the at least one digital representation including one or moredigital registration landmarks corresponding to the one or more physicalregistration landmarks on the body region; one or more instructions 3580for adding one or more digitally registered injection sites to the atleast one digital representation of the body region, the one or moredigitally registered injection sites registered relative to the one ormore digital registration landmarks; one or more instructions 3585 forgenerating one or more output signals having information for controllingone or more controllable light-emitting elements to illuminate alocation on a surface of the body region of the individual correspondingin location to at least one of the one or more digitally registeredinjection sites; one or more instructions 3590 for receiving one or moresecond digital images of the body region of the individual, the one ormore second digital images of the body region including the one or morephysical registration landmarks and one or more illuminated injectionsites; and one or more instructions for generating one or more outputsignals having information for adjusting the one or more controllablelight-emitting elements so as to align the one or more illuminatedinjection sites relative to the one or more physical registrationlandmarks on the body region to substantially correspond to the at leastone digital representation of the body region.

In one embodiment the system including a computer processor andnon-transitory signal-bearing medium bearing one or more instructionsfor generating an injection guide can further include one or moreinstructions for registering a position of an injector relative to aninjection site. In one embodiment, the non-transitory signal-bearingmedium includes one or more instructions for registering a position ofan injector relative to one or more illuminated injection sites; and oneor more instructions for issuing an alarm if the injector is in anincorrect position of the body region relative to the one or moreilluminated injection sites. In one embodiment, the non-transitorysignal-bearing medium includes one or more instructions for registeringa position of an injector relative to one or more illuminated injectionsites; and one or more instructions for recording one or more injectionevents at the illuminated injection site. In one embodiment, theinjector can be registered relative to an illuminated injection sitebased on feedback from an image capture device included in the system(see, for example, FIGS. 31 and 35). For example, the computer processorcan include one or more instructions for recognizing an injector oraccessory thereof in a captured image and assessing the injector'sproximity to an illuminated injection site in the same captured imageand issuing an alert if the injector is not properly located. In oneembodiment, a real-time video stream may be used to monitor injectorlocation. An injection event at the illuminated injection site can berecorded by the computer processor as, for example, an image. In oneembodiment, the injector can be registered relative to the illuminatedinjection site based on interaction of some component of the injectorwith the illuminated injection site. For example, the injector mayinclude an injector-tracking device including one or more photo-sensorsthat are activated when a specific portion of the injector, e.g., theinjection needle, crosses the beam of light illuminating an injectionsite. In one embodiment, the injector-tracking device can directly issuean audible, visible, or haptic alert or alarm. In one embodiment, theinjector-tracking device can send a signal, e.g., a radio-frequencysignal, to another device, e.g., the computer processor, a headset, aphone, or other device, which then issues an alarm.

In one embodiment, non-transitory signal-bearing medium bearing one ormore instructions for generating an injection guide can include one ormore instructions for acquiring one or more digital images of the bodyregion of the individual in at least one first expression state and atleast one second expression state; one or more instructions forcomparing the one or more digital images of the body region of theindividual in the at least one first expression state and the at leastone second expression state to determine an injection-treatment plan;and one or more instructions for adding the one or more digitallyregistered injection sites to the at least one digital representation ofthe body region based on the injection-treatment plan.

In one embodiment, an article of manufacture includes non-transitorysignal-bearing medium bearing one or more instructions for guidinginjection in an individual. The non-transitory signal-bearing mediumincludes one or more instructions for referencing one or more digitallyregistered injection sites on a three-dimensional model of a body regionof an individual with one or more digital injection sites; and one ormore instructions for controlling illumination of injection informationfor each digital injection site onto a surface of the body region of theindividual. In one embodiment, the one or more digitally registeredinjection sites are represented by coordinates relative to thethree-dimensional model of the body region. In one embodiment, the oneor more digitally registered injection sites are represented bycoordinates relative to one or more digital registration landmarkscorresponding to one or more physical registration landmarks on the bodyregion. In one embodiment, the one or more digital injection sites arerepresented by a visible mark, e.g., a color or pattern, on a digitaldisplay device, e.g., a computer monitor. The one or more digitalinjection sites substantially correspond to one or more illuminatedinjection sites. The injection information can include, but is notlimited to, a physical injection site on the body region and/orinformation pertaining to the injection, e.g., a type of injectableagent, a type of injector, injection dosing, injection timing, injectionsequence, injection angle, and/or injection depth.

FIG. 36 illustrates aspects of an article of manufacture for use ingenerating an injection guide. Article of manufacture 3600 includesnon-transitory signal-bearing medium 3610 bearing one or moreinstructions for generating an injection guide. The non-transitorysignal-bearing medium includes one or more instructions 3620 forreceiving one or more digital images of a body region of an individualincluding one or more physical registration landmarks; one or moreinstructions 3630 for generating at least one digital representation ofthe body region using the one or more digital images, the at least onedigital representation including one or more digital registrationlandmarks corresponding to the one or more physical registrationlandmarks on the body region; one or more instructions 3640 for addingone or more digitally registered injection sites to the at least onedigital representation of the body region, the one or more digitallyregistered injection sites registered relative to the one or moreregistration landmarks; and one or more instructions 3650 for generatingone or more output signals having information for controlling one ormore controllable light-emitting elements to illuminate a location on asurface of the body region of the individual corresponding in locationto at least one of the one or more digitally registered injection sites.

In one embodiment, a method for guiding injection in an individualincludes projecting an injection-treatment pattern on a surface of abody region of the individual, the injection-treatment pattern part of adigitally-rendered injection-treatment plan and including one or moreilluminated injection sites; placing one or more marks on the surface ofthe body region of the individual, the one or more marks substantiallycorresponding in location to the one or more illuminated injectionsites; and injecting at least one injectable agent into an underlyingtissue of the body region at or near at least one of the one or moremarks.

FIG. 37 illustrates aspects of a method 3700 for guiding injection in anindividual. Method 3700 includes projecting injection-treatment pattern3710 on a surface of body region 3715 of individual 3720. Injectiontreatment-pattern 3710 can include one or more illuminated injectionsites 3705. In one embodiment, injection-treatment pattern 3710 canfurther include one or more projected annotations 3706. In thenon-limiting example shown in FIG. 37, one or more projected annotations3706 are numbers indicating the sequence of injection. However, one ormore projected annotations 3706 can include information regarding one ormore of an injectable agent, an injector type, a dosage, a sequence ofinjection, a timing of injection, an angle of injection, and/or a depthof injection. Controllable light emitting element 3725 controllablyprojects injection-treatment pattern 3710 onto the surface of bodyregion 3715 of individual 3720. Controllable light emitting element 3725is operably connected to computing device 3730, the latter of whichcontrols projection from controllable light emitting element 3725.Controllable light emitting element 3725 projects injection-treatmentpattern 3710 including one or more illuminated injection sites 3705 andone or more projected annotations 3706 in accordance withdigitally-rendered injection-treatment plan 3735 included in computingdevice 3730. Digitally-rendered injection-treatment plan 3735 caninclude at least one digital representation of the body region of theindividual. The at least one digital representation of the body regioncan include one or more digital registration landmarks corresponding toone or more physical registration landmarks on the body region of theindividual. The at least one digital representation of the body regioncan further include one or more digitally registered injection sitescorresponding to the one or more injection sites illuminated on thesurface of the body region. The digitally-rendered injection-treatmentplan can further include one or more digitally-rendered annotationscorresponding to the one or more projected annotations.

Method 3700 further includes placing one or more marks 3740 on thesurface of body region 3715 with a marking tool 3745. Marking tool 3745can include a pen or other marking device. Alternatively, marking can bedone using one or more adhesive pieces, e.g., small round stickers. Oneor more marks 3740 substantially correspond in location to the one ormore illuminated injection sites 3705. One or more annotation marks 3760may also be placed on the surface of the body region substantiallycorresponding to one or more projected annotations 3706. Method 3700further includes injecting one or more injectable agents with injector3750 at one or more marks 3740 wherein one or more marks 3740 form asubstantially equivalent injection-treatment pattern 3710 on the surfaceof body region 3715.

FIG. 38 illustrates aspects of a system for registering one or moreilluminated injection sites. System 3800 includes computing device 3810and non-transitory signal-bearing medium 3820 bearing one or moreinstructions for registering one or more illuminated injection sites.Non-transitory signal-bearing medium 3820 includes one or moreinstructions 3830 for acquiring a real-time image of a body region of anindividual; one or more instructions 3840 for locating one or morephysical registration landmarks on the real-time image of the bodyregion of the individual; one or more instructions 3850 for matching theone or more physical registration landmarks with one or more digitalregistration landmarks in an injection-treatment plan, theinjection-treatment plan including one or more digital injection sites;one or more instructions 3860 for mapping the one or more digitalinjection sites to one or more physical injection sites; and one or moreinstructions 3870 for controlling illumination of the one or morephysical injection sites. In one embodiment, system 3800 optionallyincludes at least one image capture device 3880 and at least onecontrollable light emitting element 3885 operably connected via awireless or wired transmission means 3890 to computing device 3810. Inone embodiment, the injection-treatment plan is a digitally-renderedinjection-treatment plan created on a computing device and stored on thecomputing device or other storage medium. In one embodiment, theinjection-treatment plan includes at least one digital representation ofa body region of an individual. In one embodiment, the digital injectionsites include digitally registered injection sites, registered relativeto one or more digital registration landmarks.

The state of the art has progressed to the point where there is littledistinction left between hardware, software, and/or firmwareimplementations of aspects of systems; the use of hardware, software,and/or firmware is generally (but not always, in that in certaincontexts the choice between hardware and software can becomesignificant) a design choice representing cost vs. efficiency tradeoffs.There are various vehicles by which processes and/or systems and/orother technologies described herein can be effected (e.g., hardware,software, and/or firmware), and that the preferred vehicle will varywith the context in which the processes and/or systems and/or othertechnologies are deployed. For example, if an implementer determinesthat speed and accuracy are paramount, the implementer may opt for amainly hardware and/or firmware vehicle; alternatively, if flexibilityis paramount, the implementer may opt for a mainly softwareimplementation; or, yet again alternatively, the implementer may opt forsome combination of hardware, software, and/or firmware. Hence, thereare several possible vehicles by which the processes and/or devicesand/or other technologies described herein can be effected, none ofwhich is inherently superior to the other in that any vehicle to beutilized is a choice dependent upon the context in which the vehiclewill be deployed and the specific concerns (e.g., speed, flexibility, orpredictability) of the implementer, any of which may vary. Those skilledin the art will recognize that optical aspects of implementations willtypically employ optically-oriented hardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations can include software or other control structures.Electronic circuitry, for example, may have one or more paths ofelectrical current constructed and arranged to implement variousfunctions as described herein. In some implementations, one or moremedia can be configured to bear a device-detectable implementation whensuch media hold or transmit a device detectable instructions operable toperform as described herein. In some variants, for example,implementations can include an update or modification of existingsoftware or firmware, or of gate arrays or programmable hardware, suchas by performing a reception of or a transmission of one or moreinstructions in relation to one or more operations described herein.Alternatively or additionally, in some variants, an implementation caninclude special-purpose hardware, software, firmware components, and/orgeneral-purpose components executing or otherwise invokingspecial-purpose components. Specifications or other implementations canbe transmitted by one or more instances of tangible transmission mediaas described herein, optionally by packet transmission or otherwise bypassing through distributed media at various times.

Alternatively or additionally, implementations may include executing aspecial-purpose instruction sequence or otherwise invoking circuitry forenabling, triggering, coordinating, requesting, or otherwise causing oneor more occurrences of any functional operations described above. Insome variants, operational or other logical descriptions herein may beexpressed directly as source code and compiled or otherwise invoked asan executable instruction sequence. In some contexts, for example, C++or other code sequences can be compiled directly or otherwiseimplemented in high-level descriptor languages (e.g., alogic-synthesizable language, a hardware description language, ahardware design simulation, and/or other such similar mode(s) ofexpression). Alternatively or additionally, some or all of the logicalexpression may be manifested as a Verilog-type hardware description orother circuitry model before physical implementation in hardware,especially for basic operations or timing-critical applications. Thoseskilled in the art will recognize how to obtain, configure, and optimizesuitable transmission or computational elements, material supplies,actuators, or other common structures in light of these teachings.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those skilled within the art that each function and/oroperation within such block diagrams, flowcharts, or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof. Inone embodiment, several portions of the subject matter described hereincan be implemented via Application Specific Integrated Circuits (ASICs),Field Programmable Gate Arrays (FPGAs), digital signal processors(DSPs), or other integrated formats. However, some aspects of theembodiments disclosed herein, in whole or in part, can be equivalentlyimplemented in integrated circuits, as one or more computer programsrunning on one or more computers (e.g., as one or more programs runningon one or more computer systems), as one or more programs running on oneor more processors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, the mechanisms ofthe subject matter described herein are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the subject matter described herein applies regardless ofthe particular type of signal bearing medium used to actually carry outthe distribution.

In a general sense, those skilled in the art will recognize that thevarious embodiments described herein can be implemented, individuallyand/or collectively, by various types of electro-mechanical systemshaving a wide range of electrical components such as hardware, software,firmware, and/or virtually any combination thereof and a wide range ofcomponents that may impart mechanical force or motion such as rigidbodies, spring or torsional bodies, hydraulics, electro-magneticallyactuated devices, and/or virtually any combination thereof.Consequently, as used herein “electro-mechanical system” includes, butis not limited to, electrical circuitry operably coupled with atransducer (e.g., an actuator, a motor, a piezoelectric crystal, a MicroElectro Mechanical System (MEMS), etc.), electrical circuitry having atleast one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of memory(e.g., random access, flash, read only, etc.)), electrical circuitryforming a communications device (e.g., a modem, communications switch,optical-electrical equipment, etc.), and/or any non-electrical analogthereto, such as optical or other analogs. Those skilled in the art willalso appreciate that examples of electro-mechanical systems include butare not limited to a variety of consumer electronics systems, medicaldevices, as well as other systems such as motorized transport systems,factory automation systems, security systems, and/orcommunication/computing systems. Those skilled in the art will recognizethat electro-mechanical as used herein is not necessarily limited to asystem that has both electrical and mechanical actuation except ascontext may dictate otherwise.

In a general sense, the various aspects described herein can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, and/or any combination thereof and can beviewed as being composed of various types of “electrical circuitry.”Consequently, as used herein “electrical circuitry” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of memory (e.g., random access, flash, readonly, etc.)), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, optical-electricalequipment, etc.). The subject matter described herein can be implementedin an analog or digital fashion or some combination thereof.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into animage processing system. A typical image processing system generallyincludes one or more of a system unit housing, a video display device,memory such as volatile or non-volatile memory, processors such asmicroprocessors or digital signal processors, computational entitiessuch as operating systems, drivers, applications programs, one or moreinteraction devices (e.g., a touch pad, a touch screen, an antenna,etc.), control systems including feedback loops and control motors(e.g., feedback for sensing lens position and/or velocity; controlmotors for moving/distorting lenses to give desired focuses). An imageprocessing system can be implemented utilizing suitable commerciallyavailable components, such as those typically found in digital stillsystems and/or digital motion systems.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into a dataprocessing system. A data processing system generally includes one ormore of a system unit housing, a video display device, memory such asvolatile or non-volatile memory, processors such as microprocessors ordigital signal processors, computational entities such as operatingsystems, drivers, graphical user interfaces, and applications programs,one or more interaction devices (e.g., a touch pad, a touch screen, anantenna, etc.), and/or control systems including feedback loops andcontrol motors (e.g., feedback for sensing position and/or velocity;control motors for moving and/or adjusting components and/orquantities). A data processing system can be implemented utilizingsuitable commercially available components, such as those typicallyfound in data computing/communication and/or networkcomputing/communication systems.

Those skilled in the art will recognize that at least a portion of thedevices and/or processes described herein can be integrated into a motesystem. Those having skill in the art will recognize that a typical motesystem generally includes one or more memories such as volatile ornon-volatile memories, processors such as microprocessors or digitalsignal processors, computational entities such as operating systems,user interfaces, drivers, sensors, actuators, applications, programs,one or more interaction devices (e.g., an antenna USB ports, acousticports, etc.), control systems including feedback loops and controlmotors (e.g., feedback for sensing or estimating position and/orvelocity; control motors for moving and/or adjusting components and/orquantities). A mote system may be implemented utilizing suitablecomponents, such as those found in mote computing/communication systems.Specific examples of such components entail such as Intel Corporation'sand/or Crossbow Corporation's mote components and supporting hardware,software, and/or firmware.

In certain cases, use of a system or method may occur in a territoryeven if components are located outside the territory. For example, in adistributed computing context, use of a distributed computing system mayoccur in a territory even though parts of the system may be locatedoutside of the territory (e.g., relay, server, processor, signal-bearingmedium, transmitting computer, receiving computer, etc. located outsidethe territory). A sale of a system or method may likewise occur in aterritory even if components of the system or method are located and/orused outside the territory.

Further, implementation of at least part of a system for performing amethod in one territory does not preclude use of the system in anotherterritory.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “operably coupled to” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In some instances, one or more components can be referred to herein as“configured to,” “configured by,” “configurable to,” “operable/operativeto,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.Those skilled in the art will recognize that such terms (e.g.“configured to”) can generally encompass active-state components and/orinactive-state components and/or standby-state components, unlesscontext requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationscan be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of the subject matter described herein.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

Various non-limiting embodiments are described herein as PropheticExamples.

PROPHETIC EXAMPLES Example 1 Generating an Illuminated Injection Guidefor Cosmetic Treatment of a Facial Region with a Neurotoxin

A system and method are described for generating an illuminatedinjection guide for cosmetic treatment of a facial region, e.g.,forehead, of an individual with an injectable agent, e.g., botulinumtoxin. The system includes a computing device including a processor,e.g., a desktop computer, and a non-transitory signal-bearing mediumbearing one or more instructions implemented on the desktop computer.The system can optionally include one or more image capture devices forcapturing digital images of the facial region of the individual.

A digital representation of the face of an individual is generated fromone or more digital images of the individual's face, including at leasta portion of the individual's forehead. The one or more digital imagesare received by the desktop computer either from a second computingdevice via wired or wireless transmission or from the one or more imagecapture devices. For the latter, two charge-coupled device cameras and aprojector connected to the desktop computer are used to scan the bodyregion of the individual's face, as described in Feng et al. Brit. J.Oral Maxillofacial Surg. (2010) 48:105-109, which is incorporated hereinby reference. The individual's face is exposed to structured light,which the cameras collects upon reflection to obtain an opticalrepresentation of the body region by a point cloud of up to 300,000points in three-dimensional coordinates. The three-dimensionalcoordinates are acquired by the computer and used to construct a digitalrepresentation of the face using a CAD/CAM software package, e.g.,Geomagic Studio (Morrisville, N.C.). One or more physical registrationlandmarks, e.g., anatomical features of the face, are incorporated intothe digital representation of the face as digital registrationlandmarks.

Digitally registered injection sites are added to the digitalrepresentation of the individual's face. The digitally registeredinjection sites can be added automatically by the computing device basedon a preprogrammed injection-treatment plan. Alternatively, thedigitally registered injection sites are added to the digitalrepresentation of the individual's face by a physician or otherpractitioner using a user input device, e.g., a keyboard or touchpadassociated with the desktop computer. The physician or otherpractitioner may work directly with the individual to position thedigitally registered injection sites so as to attain a desired outcome,e.g., reducing wrinkles without excessively immobilizing facial muscles.

The digitally registered injection sites are added to the digitalrepresentation in an injection-treatment pattern. Theinjection-treatment pattern includes a triangular pattern of 9 to 13digitally registered injection sites which are added to the region ofthe digital representation corresponding to the individual's forehead.The 9 to 13 digitally registered injection sites correspond to intendedinjections sites for botulinum toxin on the individual's forehead. Thedigitally registered injection sites are added to the digitalrepresentation relative to physical registration landmarks representedby digital registration landmarks. In this example, the physicallandmarks include the eye brows, frontal scalp line, and midline of theforehead. The digitally registered injection sites are registered 0.5centimeters below the lateral brow; in the midpupillary line, halfwaybetween the eyebrow and the frontal scalp on each side of the model; atthe vertex of the forehead; at the midline just below the meeting of theeyebrows; at the midline of the forehead, halfway between the nasalradix and the vertex of the scalp; and over the corrugators,approximately 1 centimeter above the medial portion of the each eyebrow(see, e.g., Bain et al., Aesthetic Surg. J. (2006) 26:617-619, which isincorporated herein by reference).

The digitally registered injection sites further include informationregarding treatment parameters in the form of letters, number, and/orcolors. The digitally registered injection site are represented by “B3”to represent 3 Units of botulinum toxin to be injected at said site.Typical dosages of botulinum toxin per injection site range from 1 to 6Units. The placement of injection sites as well as the treatmentpatterns can be either automatically added to the digital representationor added by a physician or other practitioner using a user input device.The physician or other practitioner can also decide how many unitsshould be injected per injection site based on the depth and/orintensity of the wrinkles on the individual's forehead, and add thatinformation to the digital representation.

The digital representation including the digitally registered injectionsites corresponding to one or more illuminated injection sites and oneor more digital registration landmarks corresponding to one or morephysical registration landmarks is directly by the computing device onwhich it was generated to proceed with guided injection usingilluminated injection sites or can be sent via a wireless transmissionto another computing device for actual injection treatment.

Example 2 Illuminating Injection Sites on the Surface of a Facial Regionof an Individual for Guided Injection of Botulinum Toxin

A system and method of guiding injection in an individual is described.The system consists of controllable light-emitting elements, e.g., laserdiodes, wired to a computing device including a processor, e.g., alaptop computer, and an image capture device, e.g., a digital camera. Adigital representation of the facial region of an individual in need oftreatment is received by the computing device via the internet, from areferring physician. The digital representation includes digitalregistration landmarks corresponding to physical registration landmarkson the face of the individual. The physical registration landmarksinclude anatomical features, e.g., nose, eyes, cheeks, wrinkles, and thelike, as well as pigmented areas, e.g., freckles associated with thefacial region of the individual. The digital representation alsoincludes digitally registered injection sites that have been registeredrelative to the digital registration landmarks. In this example, thedigitally registered injection sites are added to the digitalrepresentation of the facial region in accordance with aninjection-treatment plan, by the referring physician using one or moreof the methods described herein prior to transmission of the digitalrepresentation to the laptop computer.

The laptop computer is operable to control the controllable laser diodesto emit light onto the surface of the facial region of the individual inaccordance with the injection-treatment plan. A first set of laserdiodes emits red light, a second set of laser diodes emits green light,and a third set of laser diodes emits blue light. The color of lightemitted depends upon the dose of botulinum toxin required at a givenilluminated injection site. The illuminated injection sitescorresponding to the digitally registered injection sites are arrangedin an injection-treatment pattern. In this example, theinjection-treatment pattern of illuminated injection sites is arrangedfor treatment of the glabella region, i.e., the space between theeyebrows. In this instance, the glabella region can be divided into thesuperior-lateral region and the central and inferomedial regions.Injection sites are illuminated on the superior-lateral region over themedial portion of the corrugators muscle near its origin. Additionalinjection sites are illuminated over the mid portion of the musclebelly. Each of these sites is illuminated with red light indicatingtreatment with 5 units of botulinum toxin. In addition, injection sitesare illuminated over the middle of the procerus muscle belly which isslightly off midline at the level of the superior orbital rims. Thispattern is repeated on the other side. Each of these sites isilluminated with green light indicating treatment with 6 units ofbotulinum toxin. Injection sites are illuminated over the depressorsupercilli muscle, which is approximately 1 centimeter above the medialcanthal tendon on both sides. Each of these sites is illuminated withblue light indicating treatment with 3 units of botulinum toxin.

A physician or other practitioner prepares the botulinum toxin, e.g.,botulinum toxin A (sold under the trademark BOTOX), for injection. A 100Unit vial of BOTOX, which has been stored frozen, is thawed and mixedwith 2.5-4.0 milliliters (ml) of 0.9% non-preserved sterile salinesolution to create a final concentration of 40-25 Units/ml. Salineincluding a preservative or water for injection (WFI) can also be usedfor this purpose.

In some instances, depending on the sensitivity/pain threshold of theindividual, the surface of body region is coated with a layer ofanesthetic cream, e.g., a eutectic mix of the local anestheticslidocaine (2.5%) and prilocaine (2.5%), prior to injection.Alternatively or in addition, the surface of the body region is cooledwith application of an ice pack for 10-15 minutes as a means of reducingthe pain of injection and/or post-injection swelling. A 1 or 3 mlsyringe with a 30-gauge needle is used for injection, although needlesranging in gauge from 27 to 32 can be used for this purpose. Appropriatelength needles for this purpose include ½ inch (12.7 mm), 5/16 inch (8mm) and 3/16 inch (5 mm) lengths. A syringe including a 30-gauge needleis filled with the appropriately prepared botulinum toxin, and theneedle is inserted into the underlying tissue of the body region at anilluminated injection site, and the appropriate amount of botulinumtoxin is injected based on the color of the illuminated injection site.Similar steps are repeated for additional injections until all theilluminated injection sites of the treatment pattern have been injected.In some treatments a single syringe may be filled with enough botulinumtoxin for the entire treatment pattern, and the needle is changedbetween injections, or the same needle is used for all injections.

The image capture device, e.g., digital camera, of the system providesfeedback as to where the illuminated injection sites are relative to thephysical registration landmarks. For example, the digital cameracaptures images of the illuminated injection sites on the surface of thefacial region and including the physical registration landmarks. Thisinformation is processed by tracking software in the laptop computer,and signals are sent to the controllable laser diodes to adjust thepositioning of where they are illuminating the surface of the bodyregion, in order to keep the illuminated injection sites appropriatelyregistered.

The individual may return from 30 to 120 days later for a repeat courseof injections, depending upon the sustainability of the treatment. Inrepeat visits, the same injection-treatment pattern of illuminatedinjection sites may be used, if appropriate. Alternatively, thephysician or other practitioner may alter the illuminated injectionsites and/or the associated treatment parameters.

Example 3 Illuminating One or More Injection Sites on the Surface of aFacial Region of an Individual for Guided Injection of a HyaluronicFiller

Generation and use of one or more illuminated injection sites in aninjection-treatment pattern is described. The injection-treatmentpattern is part of an injection-treatment plan designed to treat theskin folds associated with the nasolabial folds, i.e., “laugh lines,” ofan individual's face with injected hyaluronic acid filler.

A digital representation is generated from one or more digital images ofat least a portion of an individual's face, with particular emphasis onthe nasolabial folds. The digital representation is generated using theimage capture methods described in Example 1. Alternatively, the digitalrepresentation of the individual's face is generated using a PRIMOSoptical three-dimensional in vivo skin measurement device(GFMesstechnik, Teltow, Germany). This system projects structured light,e.g., a parallel stripe pattern, onto the face of the individual, thereflection of which is captured on a charge-coupled device chip of ashooting camera through a shooting optic. The measurement systemconsists of a freely movable optical measurement head (with anintegrated micro-mirror projector, a projection optic, a shooting optic,and a charge-coupled device recording camera) together with a computersystem. A three-dimensional effect is achieved by deflection of theparallel projection stripes by the topography the individual's face. Thedeflections are digitalized and quantitatively evaluated using software.Mathematical algorithms are used to generate a three-dimensional imageof the individual's face, which becomes the basis for the digitalrepresentation (see, e.g., Levenberg Eur. J. Dermatol. (2010)20:615-619, which is incorporated herein by reference).

A pattern of one to ten digitally registered injection sites is added tothe digital representation of the individual's face, each injection siterepresented by a circle. Injection of hyaluronic acid into thenasolabial folds can be done at a single injection site by the processof threading or at multiple injection sites along the fold. Threadinginvolves injecting the needle under the skin all the way to a distantpoint and then slowly removing the needle while releasing the injectableagent. To accommodate threading, in which the injection needle isinjected at an angle of about 10 to 30 degrees relative to plane of theskin surface, annotations are added to the digital representation andare projected onto the individual's face. For example, an annotationindicating an angle of injection, e.g., 25 degrees, at the illuminatedinjection sites is added to the digital representation. For multipleinjection sites, multiple digitally registered injection sites are addedto the digital representation relative to a linear path along thenasolabial fold.

Annotations are added to the digital representation to indicate thedosage of hyaluronic acid filler to be used at each injection site. Forinjection into the nasolabial folds, the injection volume can be as highas 6 ml per fold, although the preferable volume is 1-3 ml per fold, anddepends upon the depth of the fold and how much “correction” is desiredby the individual (see, e.g., Prager & Steinkraus Eur. J. Dermatol.(2010) 20:748-752, which is incorporated herein by reference). Thephysician or other practitioner can determine the appropriate dosage ofthe hyaluronic filler by assessing the depth of the nasolabial fold fromeither viewing the individual's face directly or viewing the capturedand processed three-dimensional image of the individual's face on acomputer monitor. Alternatively, the computing device used to generatethe digital representation can include one or more algorithms todetermine the appropriate dosage based on the captured imageinformation.

The surface of the individual's face is wiped with a disinfectant, e.g.,rubbing alcohol, and the injection sites are illuminated using a miniprojector, e.g., a 3M™ Mobile Projector MP220 (from 3M, St. Paul,Minn.). The illuminated injection sites correspond to the digitallyregistered injection sites. The projector also projects the annotationsonto the surface of the body region.

The hyaluronic acid filler for injection is preferably one of the agentsapproved by the United States Food & Drug Administration (FDA), e.g.,Restylane® (from Medicis Aesthetics Inc., Scottsdale, Ariz.). Restylane®is provided by the manufacturer in a disposable glass syringe. Needles ½inch in length and either 29 or 30 gauge are recommended for use withthis product. The hyaluronic acid filler is injected at the illuminatedinjection sites with instructions from the annotations, the annotationsincluding treatment parameters and/or other instructions pertinent tothe injection-treatment plan.

Example 4 A System for Feedback Guided Injection of an Individual withBlepharospasm (Eye-Lid Spasm)

An embodiment of a system and method are described for guidingneurotoxin injection in an individual for treatment of blepharospasm(eye-lid spasm). The system includes controllable light-emittingelements configured to emit non-destructive light, a computing deviceincluding a processor, and an injector-tracking device. The system canalso optionally include an image capture device.

A digital representation of the facial region of an individual withblepharospasm is received by the computing device of the system, thedigital representation including digital registration landmarkscorresponding to physical registration landmarks. The physicalregistration landmarks include the inner and outer canthi of both eyes,the pre-tarsal orbicularis oculi of the upper lid, the lateralpre-tarsal orbicularis oculi of the lower lid, the levator palpebraesuperioris, the medial lower lid, the center of the upper lip, the outercorners of the mouth, the intersection of the frontal bone and two nasalbones of the skull (nasion), the tip of the nose (pronasale), a subnasalpoint, and a chin point.

The digital representation of the individual's face further includesdigitally registered injection sites added to the digital representationof the eye-lid area of the individual. The digitally registeredinjection sites are represented by crosshairs to indicate injectionsites. The crosshairs vary in color to indicate specific treatmentparameters, e.g., the dose of botulinum toxin used at each injectionsite. For the treatment of blepharospasm with a botulinum toxin, e.g.,BOTOX® (from, Allergan, Inc., Irvine, Calif.), the digitally registeredinjection sites are registered relative to the eye-lid regioncorresponding to regions either proximal to or over the medial andlateral pre-tarsal orbicularis oculi of the upper lid and into thelateral pre-tarsal orbicularis oculi of the lower lid. Care is taken toavoid registering injection sites near the levator palpebrae superiorisand the medial lower lid to avoid complications of ptosis and diplopia,respectively. A series of digitally registered injection sitesrepresented by crosshairs and corresponding to 5 to 10 individualinjection sites per eye are added to the digital representation. Inaddition, annotation is added to the digital representation indicatingthe number units of botulinum toxin to be injected, e.g., 1.25 to 3.0units per injection, for a total of 30 units per eye. The digitallyregistered injection sites are also registered so as to avoid injectioninto an underlying blood vessel. The location of underlying bloodvessels are imaged using a light-emitting diode illumination system suchas that described in U.S. Patent Application 2008/0306392, which isincorporated herein by reference. Information regarding blood vessellocation is added to the digital representation of the individual's faceand avoided when placing the digitally registered injection sites.

The injection sites are illuminated onto the surface of the individual'sface with laser diodes, the illuminated injection sites corresponding tothe digitally registered injection sites. Each injection site on thesurface of the individual's face is sequentially illuminated with acrosshair approximately 9 millimeters in length. The crosshair isgenerated using a crosshair diffractive diffuser (DE-R 201 Cross-5 fromFrankfurt Laser Co., Germany) and a red (633 nm) laser diode.

BOTOX is prepared for injection per the manufacturer's instructions. A30 gauge needle with a length of 4 mm is used for injecting 1.5 units ofBOTOX per injection site at the illuminated injection sites. A syringeincluding the 30 gauge needle includes a removable injector-trackingdevice for tracking movement of the syringe relative to the illuminatedinjection sites. The injector-tracking device includes a photo-sensorthat is a photo diode with high performance in ambient light, e.g., thedimmed background light in a treatment room, as described in U.S. Pat.No. 7,891,570, which is incorporated herein by reference. Theinjector-tracking device includes a processor capable of subtracting outsignals due to the ambient light relative to the bright red illuminatedinjection site. The injector-tracking device further includes aminiature audio chip operably connected to the photo-sensor andconfigured to emit a peeping sound when the photo-sensor is activated byproximity of the syringe to the illuminated injection site. BOTOX isinjected into the underlying eyelid area to a depth of 2 mm. Eachtreatment lasts approximately three months, following which theprocedure may be repeated. At that time, the injection-treatment patternand/or the treatment parameters may be modified.

Example 5 Illuminating Pattern of Injection Sites for Self-Injection ofOvulation Stimulating Hormones

Systems and methods are described for illuminating a pattern ofinjection sites onto the upper thigh of an individual as part of aninjection-treatment plan for self-injecting hormones to induce ovulationfor use in in-vitro fertilization.

A digital image of the upper thigh of an individual is acquired usingone of the methods previously described herein. Alternatively, digitalimages of the upper thigh of the individual are acquired with a standarddigital camera and combined with images of blood vessels at or near thesurface of the skin. An example of an apparatus for imaging bloodvessels is described in U.S. Pat. No. 6,522,911, which is incorporatedherein by reference. The digital images further ideally include one ormore physical registration landmarks, e.g., freckles, moles, tattoos,etc., for registering digitally registered injection sites. If novisible landmarks are present on the surface of the body region, thephysician or other practitioner can add markings, e.g., ink or adhesivepieces, to the upper thigh for use as physical registration landmarks.The digital images are used by a computing device to generate a digitalrepresentation of the upper thigh including digital registrationlandmarks corresponding to the physical registration landmarks.

A series of digitally registered injection sites are added to thedigital representation of the body region. The number of digitallyregistered injection sites is dependent upon the number of plannedinjections during the ovulation cycle. The number of planned injectionsis further dependent upon the types of injectable hormones used and themenstrual cycle of the individual. Eggs are matured in vivo prior toharvesting for in vitro fertilization using some combination ofgonadotropin-releasing hormone (GnRH) antagonists, follicle-stimulatinghormone (FSH), and human chorionic gonadotropin (hCG). In this example,the injection-treatment plan is individualized to the individual'smenstrual cycle and includes multiple injections of the GnRH antagonistleuprolide acetate, e.g., Lupron, and FSH over the course of 14 to 21days, and a final injection with hCG two days prior to harvesting eggs.Digitally registered injection sites are added to the digitalrepresentation of the upper thigh, the digitally registered injectionsites represented by letters, numbers, and shapes. The letter, number,and shapes further indicate treatment parameters, e.g., the type of drugto be injected, the dose of drug to be injected, and/or the day in thetreatment cycle. Alternatively or in addition, treatment parameters areincluded as annotations that are projected at or near illuminatedinjection sites.

The digital representation of the upper thigh, including the digitallyregistered injection sites, the digital registration landmarks, anyannotations, and instructions for projecting the injection guide, arereceived by a computing device incorporated in a head-mounted system.The head-mounted system includes the computing device, controllablelight-emitting elements, and an image capture device. An illustrativeexample of a head-mounted system and an annotated injection-treatmentpattern are provided in FIG. 39. FIG. 39A shows head-mounted system 3900worn on head region 3905 of an individual. In this example, head-mountedsystem 3900 is attached to a strap encircling head region 3905, but thesystem could be incorporated into a hat or other head covering.Head-mounted system 3900 emits light beam 3910 onto the surface of theupper thigh 3915. Light beam 3910 illuminates injection site 3920.

FIG. 39B illustrates a non-limiting example of an injection guide 3925in which illuminated injection sites and annotations are projected ontothe surface of a body region 3930. The illuminated injection sites arealigned based on physical registration landmarks 3935, e.g., two or morefreckles, on the surface of the upper thigh. In general, the injectioncycle is as follows: On day 1 (which corresponds to day 21 of themenstrual cycle) the injection cycle is initiated by injecting the firstLupron injection. On day 9-12 (which corresponds to the day after thebeginning of menstruation and is variable depending upon number of daysin cycle) initiate 7 days of FSH injection. On day 16, finish injectioncycle with the last injections of Lupron and FSH, and a single injectionof HCG. Egg retrieval is performed 2 days after HCG injection. In thenon-limiting example depicted in FIG. 39B, injection sites areilluminated in a color-coded fashion onto the surface of body region3930. Injection site 3940 is illuminated with a first color, e.g., whitelight, while injection site 3945 is illuminated with a second color,e.g., green light. Each day, all injection sites are illuminated withwhite light, with the exception of the injection site of the day, whichis illuminated with a second color of light, e.g., green light. Sitesthat have been previously injected may be optionally illuminated with athird color of light, e.g., red light Annotations are projected ontobody region 3930 in proximity to injection sites 3940 and 3945,providing pieces of information related to the injection day and thedrug to be injected on a given day. For example, a first column 3950illuminated injection sites is annotated with a projected “L” for Lupronand numbered in a descending manner 3955 to indicate the first day ofLupron injection, the second day of Lupron injection, etc., out to thetwelfth day of Lupron injection. A second column 3960 and a third column3965 of illuminated injection sites are annotated with projected “L” and“FSH”, respectively, and are similarly numbered to indicate theinjection day. The fourth column 3970 has a single illuminated injectionsite reserved for the final injection of HCG two days prior toharvesting of eggs.

All of the above U.S. patents, U.S. patent application publications,U.S. patent applications, foreign patents, foreign patent applicationsand non-patent publications referred to in this specification and/orlisted in any Information Disclosure Statement, are incorporated hereinby reference, to the extent not inconsistent herewith.

With respect to the appended claims, the recited operations therein maygenerally be performed in any order. Also, although various operationalflows are presented in a sequence(s), it should be understood that thevarious operations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. A system for guiding injection in an individualcomprising: one or more controllable light-emitting elements configuredto emit non-destructive light; at least one image capture device; adigitally-rendered injection-treatment plan stored on acomputer-readable medium, the digitally-rendered injection-treatmentplan part of an injection-treatment plan and including one or moredigitally registered injection sites arranged in an injection-treatmentpattern on a digital representation of a skin surface of an individual,the one or more digitally registered injection sites registered relativeto one or more digital registration landmarks corresponding to one ormore physical registration landmarks on the skin surface of theindividual; and a computing device operably connected to the one or morecontrollable light-emitting elements and the at least one image capturedevice, the computing device including a processor and circuitryconfigured to receive the digitally-rendered injection-treatment planfrom the computer-readable medium; circuitry configured to actuate atleast one of the one or more controllable light-emitting elements toilluminate one or more injection sites on the skin surface of theindividual in the injection-treatment pattern in accordance with thedigitally-rendered injection-treatment plan; circuitry configured toreceive from the at least one image capture device one or more digitalimages of a visual field including the skin surface of the individual,the visual field including the illuminated one or more injection sitesand the one or more physical registration landmarks on the skin surfaceof the individual; and circuitry configured to adjust the at least oneof the one or more controllable light-emitting elements so as to alignthe illuminated one or more injection sites relative to the one or morephysical registration landmarks on the skin surface of the individual tosubstantially correspond to the digitally rendered injection-treatmentplan.
 2. The system of claim 1, wherein at least one of the one or morecontrollable light-emitting elements is configured to emit at least onefirst color of light and at least one second color of light.
 3. Thesystem of claim 1, wherein at least one of the one or more controllablelight-emitting elements is configured to emit a pattern of light in theshape of one or more letters, numbers, symbols, or combinations thereof.4. The system of claim 1, wherein the computing device includescircuitry configured to control one or more of a color of light or apattern of light emitted from the one or more controllablelight-emitting elements.
 5. The system of claim 1, wherein the computingdevice includes circuitry configured to actuate one of the one or morecontrollable light-emitting elements to illuminate a first injectionsite at a first location on the skin surface of the individual at afirst time point and to illuminate a second injection site at a secondlocation on the skin surface of the individual at a second time point.6. The system of claim 1, wherein the computing device includescircuitry configured to actuate the one or more controllablelight-emitting elements to illuminate each of the one or more injectionsites on the skin surface of the individual in a temporal sequence. 7.The system of claim 1, wherein at least one of the one or morecontrollable light-emitting elements is a projector, the projectoroperably coupled to the computing device to project onto the skinsurface of the individual at least a portion of the digitally-renderedinjection-treatment plan including at least one of the one or moredigitally-registered injection sites.
 8. The system of claim 7, whereinthe projected at least a portion of the digitally-renderedinjection-treatment plan includes one or more treatment parametersrepresented by one or more letters, numbers, shapes, symbols, text,colors, or combinations thereof.
 9. The system of claim 7, wherein theprojected at least a portion of the digitally-renderedinjection-treatment plan includes one or more injection status updatesrepresented by one or more letters, numbers, shapes, symbols, text,colors, or combinations thereof, wherein the one or more injectionstatus updates include at least one of a running clock, a number ofinjections completed, or a number of injections remaining.
 10. Thesystem of claim 1, wherein the at least one image capture deviceincludes at least one digital camera.
 11. The system of claim 1 whereinthe computing device includes circuitry configured to register aposition of an injector relative to the illuminated one or moreinjection sites on the skin surface of the individual in the receivedone or more digital images of the visual field of the skin surface ofthe individual; and circuitry configured to issue an alarm in responseto the registered position of the injector relative to the illuminatedone or more injection sites on the skin surface of the individual. 12.The system of claim 1 wherein the computing device includes circuitryconfigured to register a position of an injector relative to at leastone of the illuminated one or more injection sites on the skin surfaceof the individual in the received one or more digital images of thevisual field of the skin surface of the individual; and circuitryconfigured to record to a data storage device one or more injectionevents at the at least one of the illuminated one or more injectionsites on the skin surface of the individual.
 13. The system of claim 1further comprising: an injector-tracking device sized for attachment toan injector and including at least one alert component and one or morephoto-sensors, wherein the at least one alert component is configured totransmit an alert signal in response to a position of the one or morephoto-sensors relative to the illuminated one or more injection sites.14. The system of claim 1, wherein the computing device includescircuitry configured to receive one or more digital images of the skinsurface of the individual including the one or more physicalregistration landmarks from the at least one image capture device;circuitry configured to generate the at least one digital representationof the skin surface of the individual using the one or more digitalimages, the at least one digital representation including the one ormore digital registration landmarks corresponding to the one or morephysical registration landmarks on the skin surface of the individual;circuitry configured to identify an area of the skin surface of theindividual in need of treatment by comparison of the at least onedigital representation of the skin surface of the individual and atleast one stored representation of at least one comparable skin surface;circuitry configured to generate the digitally renderedinjection-treatment plan based on the identified area of the skinsurface of the individual in need of treatment; and circuitry configuredto add the one or more digitally registered injection sites to the atleast one digital representation of the skin surface of the individualbased on the digitally rendered injection-treatment plan, the one ormore digitally registered injection sites registered relative to the oneor more digital registration landmarks.
 15. The system of claim 1,further comprising: a head-mounted system, the head-mounted systemmountable to a head region of a user and including the one or morecontrollable light-emitting elements configured to emit non-destructivelight and at least one transmission unit including an antenna.
 16. Thesystem of claim 1, wherein the one or more controllable light-emittingelements configured to emit non-destructive light include at least onefirst controllable light-emitting element configured to emit a firstcolor of non-destructive light and at least one second controllablelight-emitting element configured to emit a second color ofnon-destructive light.
 17. The system of claim 1, wherein theinjection-treatment plan includes at least one treatment parameterrepresented by a color of light, a pattern of light, or a combinationthereof.
 18. The system of claim 1, further comprising: the one or morecontrollable light-emitting elements configured to emit non-destructivelight; at least one digital camera; a digitally-renderedinjection-treatment plan stored on a computer-readable medium, thedigitally-rendered injection-treatment plan part of a cosmeticinjection-treatment plan to treat one or more lines, wrinkles, folds, orpouches in need of treatment on the individual's face, thedigitally-rendered injection-treatment plan including one or moredigitally registered injection sites arranged in an injection-treatmentpattern on a digital representation of the skin surface of theindividual's face, the one or more digitally registered injection sitesregistered relative to one or more digital registration landmarkscorresponding to one or more physical registration landmarks on the skinsurface of the individual's face, the injection-treatment patternaligned with the one or more lines, wrinkles, folds, or pouches in needof treatment on the individual's face; and the computing device operablyconnected to the one or more controllable light-emitting elements andthe at least one digital camera, the computing device including theprocessor and circuitry configured to receive the digitally-renderedinjection-treatment plan from the computer-readable medium; circuitryconfigured to actuate the one or more of the controllable light-emittingelements to illuminate one or more injection sites on the skin surfaceof the individual's face in the injection-treatment pattern inaccordance with the digitally-rendered injection-treatment plan, theilluminated one or more injection sites situated over one or more lines,wrinkles, folds, or pouches in need of treatment on the individual'sface; circuitry configured to receive from the at least one digitalcamera one or more digital images of a visual field including the skinsurface of the individual's face, the visual field including theilluminated one or more injection sites and the one or more physicalregistration landmarks on the skin surface of the individual's face;circuitry configured to adjust the one or more of the controllablelight-emitting elements so as to align the illuminated one or moreinjection sites relative to the one or more physical registrationlandmarks on the skin surface of the individual's face to substantiallycorrespond to the digitally rendered injection-treatment plan.
 19. Thesystem of claim 1, further comprising: non-transitory signal-bearingmedium bearing one or more instructions executable by the computingdevice, the non-transitory signal-bearing medium including one or moreinstructions for receiving the digitally-rendered injection-treatmentplan from the computer-readable medium; one or more instructions foractuating the one or more controllable light emitting elements toilluminate the one or more injection sites on the skin surface of theindividual in the injection-treatment pattern in accordance with thedigitally-rendered injection-treatment plan; one or more instructionsfor acquiring the one or more digital images from the at least one imagecapture device, the one or more digital images including the visualfield of the skin surface of the individual including the illuminatedone or more injection sites and the one or more physical registrationlandmarks on the skin surface of the individual; and one or moreinstructions for adjusting the one or more controllable light-emittingelements so as to align the illuminated one or more injection sitesrelative to the one or more physical registration landmarks on the skinsurface of the individual to substantially correspond to thedigitally-rendered injection-treatment plan.
 20. The system of claim 1,further comprising: non-transitory signal-bearing medium bearing one ormore instructions executable by the computing device, the non-transitorysignal-bearing medium including one or more instructions for acquiringone or more digital images of the skin surface of the individualincluding the one or more physical registration landmarks with the atleast one image capture device; one or more instructions for generatingthe at least one digital representation of the skin surface of theindividual from the one or more digital images, the at least one digitalrepresentation of the skin surface of the individual including the oneor more digital registration landmarks corresponding to the one or morephysical registration landmarks on the skin surface of the individual;one or more instructions for identifying an area of the skin surface ofthe individual in need of treatment by comparison of the at least onedigital representation of the skin surface of the individual and atleast one stored representation of at least one comparable skin surface;one or more instructions for generating the digitally renderedinjection-treatment plan based on the identified area of the skinsurface of the individual in need of treatment; and one or moreinstructions for adding the one or more digitally registered injectionsites to the at least one digital representation of the skin surface ofthe individual based on the digitally rendered injection-treatment plan,the one or more digitally registered injection sites registered relativeto the one or more digital registration landmarks.
 21. The system ofclaim 1, wherein the one or more digitally registered injection sitesarranged in the injection-treatment pattern on the digitalrepresentation of the skin surface of the individual are aligned withone or more of lines, wrinkles, pouches, or folds in need of treatmentidentified in the digital representation of the skin surface of theindividual.
 22. The system of claim 20, wherein the computing deviceincludes circuitry configured to actuate the one or more of thecontrollable light-emitting elements to illuminate one or more injectionsites over one or more lines, wrinkles, pouches, or folds on the skinsurface of the individual to correspond with the one or more of thelines, wrinkles, pouches, or folds in need of treatment identified inthe digital representation of the skin surface of the individual. 23.The system of claim 1, wherein the one or more controllablelight-emitting elements configured to emit non-destructive light, the atleast one image capture device, and the computing component operablycoupled to the one or more controllable light-emitting elements and theat least one image capture device are part of a head-mounted system, thehead-mounted system mountable to a head region of a user, thehead-mounted system further including at least one transmission unitincluding an antenna, the computing device including circuitryconfigured to receive at least a portion of the digitally-renderedinjection-treatment plan through the at least one transmission unit.